2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
دعاء صبحي احمد مصطفى كديره 2182
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
.Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
دعاء صبحي احمد مصطفى كديره 2182
دlost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsivepatient
7.ID error
8.lost sample
9.sample delayed in transit
10.wrong test performed
11.Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive- Adverse event: is an event that results in unintended harm to the patient by an act of commission or omission rather than the underlying disease or condition of the patient (this includes sentinel events, hospital-acquired conditions, events that required life-sustaining intervention, and events that caused prolonged hospital stays, permanent harm, or death.
– Near miss differs from the adverse event because, in near miss, serious harm did not occur and was prevented from completion through a planned or unplanned recovery as a result of chance, prevention, mitigation. Near misses act as free lessons.
– Near misses occur with greater frequency than adverse events.
(2)Harm means:
-Impairment of structure or function of the body.
-Any deleterious effect arising therefrom.
-It includes disease, injury, suffering, disability, and death.
-refers to outcomes or results.
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious medically important event).
Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities and/or quality of life.
Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.
Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.
46 Comments
Hager esmahile ahmed esmahile elzarka
patient ID error
lost sample
sample delayed in transit
wrong test performed
أسماء شريف جمال محمود مصطفى
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
2268 شيماء محمد احمد الاحمر
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
Heba Allah Ayman Galal Nassar رقم الجلوس 2020418
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
مريم سعيد عبد الحميد حسن
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Sabah Hassan shoeep Hassan 2272
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
رضوى ابراهيم السيد احمد
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
هانم السيد ابراهيم سليمان 2415
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
آلاء بدر الدين رمضان توفيق
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
تسنيم على محمد على ابراهيم 2160
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Amira Bassyoni Mohamed Abd el halem
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
أسماء أحمد يسري علي2028
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
مها عبدالسميع حمدي الشيخ 2350
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Aisha Fathy Hosny Elsaed Farag
Lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Aisha Fathy Hosny Elsaed Farag
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
Aisha Fathy Hosny Elsaed Farag 2279
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
Aisha Fathy Hosny Elsaed Farag 2279
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Aisha Fathy Hosny Elsaed Farag 2279
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
عائشة فتحي حسني السيد فرج 2279
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
عائشة فتحي حسني السيد فرج 2279
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Aisha Fathy Hosny Elsaed Farag 2279
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
فاطمة ماهر حداد سعيد 2466
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
فاطمة ماهر حداد سعيد 2466 .. Fatima Maher Haddad Saeed
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
Azza Rifaat Youssef Jaboba 2283
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
شيماء يسري محمد الشنودي/2271
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Shimaa Yosri Mohamed Al Shenoudi 2271
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
Naira Abdelfattah Emam 2394
1. Expert analysis
2. Systems oriented
3. Responsive
Naira Abdelfattah Emam 2394
1. Expert analysis
2. Systems oriented
3. Responsive
نبيلة حشمت الله 2479
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Shaimaa Mohmmed Youssef Esmail
Non punitive
Confidential
Timely
Expert analysis
Independent
System oriented
Responsive
صفاء بهجت علي ابوطه
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
آية جمال ابوالثنا عبدالله
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
آية جمال ابوالثنا عبدالله
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
فاطمة أحمد عبد العزيز عبد العظيم 2020291
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
فاطمة أحمد عبد العزيز عبد العظيم 2020291
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
دعاء صبحي احمد مصطفى كديره
دعاء صبحي احمد مصطفى كديره 2182
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
.Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
آية جمال ابوالثنا عبدالله
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
آية جمال ابوالثنا عبدالله ناصر
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive
دعاء صبحي احمد مصطفى كديره
دعاء صبحي احمد مصطفى كديره 2182
دlost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
Aya gamal aboelthana abdallah
Characteristics of successful Reporting systems:
-Non-punitive
-supportive system
-confident
-independent
-system orientation
-expert analysis
-responsing
إيمان أحمد منصور أحمد 2020142
lost sample
sample delayed in transit
wrong test performed
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death
رضوى مسعد احمد محمد بدوي ٢٠٢١١٦٩
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsivepatient
7.ID error
8.lost sample
9.sample delayed in transit
10.wrong test performed
11.Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
زينة حسن اسماعيل عزالدين
The identification and grading of adverse events (AEs) during the conduct of clinical trials is a labor-intensive and error-prone process.
آيات عادل محمد محمد. 2021088
1/Adverse event:An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.
Near Miss:An error of commission or omission that could have harmed the patient, but serious harm did not occur and was prevented from completion through a planned or unplanned recovery. As a result of :*Chance e.g., the patient received a contraindicated drug but did not experience an adverse drug reaction)
2/Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
آيات عادل محمد محمد. 2021088
Impairment of structure or function of the body and/or any deleterious effect arising there from. §Harm includes disease, injury, suffering, disability and death.
Characteristics of successful reporting system
1. Nonpunitive
2. Confidential
3. Independent
4. Expert analysis
5. Systems oriented
6. Responsive- Adverse event: is an event that results in unintended harm to the patient by an act of commission or omission rather than the underlying disease or condition of the patient (this includes sentinel events, hospital-acquired conditions, events that required life-sustaining intervention, and events that caused prolonged hospital stays, permanent harm, or death.
– Near miss differs from the adverse event because, in near miss, serious harm did not occur and was prevented from completion through a planned or unplanned recovery as a result of chance, prevention, mitigation. Near misses act as free lessons.
– Near misses occur with greater frequency than adverse events.
(2)Harm means:
-Impairment of structure or function of the body.
-Any deleterious effect arising therefrom.
-It includes disease, injury, suffering, disability, and death.
-refers to outcomes or results.
رحمه ايمن غرابه
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious medically important event).
Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities and/or quality of life.
Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.
Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.