B1:      Type of Report
B2:      Outcome Attributed to Adverse Event
B3:      Date of Event
B4:      Date of this Report
B5:      Describe Event,  Problem or Product Use Error/Medication Error
B6:      Relevant Tests/Laboratory Data, Including Dates 
B7:      Other Relevant History, Including Preexisting Medical Conditions

B1:  Type of Report
Choose the appropriate box. Both boxes should be checked if a product problem may have caused or contributed to the adverse event.

Adverse event: Any incident where the use of a medication (drug or biologic), at any dose, human cell/tissue product, blood product, a medical device (including in vitro diagnostics) or a special nutritional product (e.g., dietary supplement, infant formula or medical food) is suspected to have resulted in an adverse outcome in a patient.

To report, it is not necessary to be certain of a cause/effect relationship between the adverse event and the use of the medical product(s) in question. Suspicion of an association is sufficient reason to report. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event. For whole blood and blood components, adverse events can include adverse outcomes in a blood donor or recipient.  

Please limit your submissions to those events that are serious. An event is classified as serious when the patient outcome attributed to the adverse event is:

• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or Permanent Damage
• Congenital anomaly/Birth Defect
• Required medical or surgical intervention to prevent permanent impairment or damage (Devices)
• Other Serious (Important Medical Events)

Please see instructions for block B2 for further information on each of these criteria.

Product problem (e.g., defects/malfunctions): Any report regarding the quality, performance, or safety of any medication, medical device or special nutritional product. In addition, please select this category when reporting device malfunctions that could lead to a death or serious injury if the malfunction were to recur.

Product problems include, but are not limited to, such concerns as:

• Suspected counterfeit product
• Suspected contamination
• Questionable stability
• Physical defects (such as color, powdering, chipped)
• Defective components for both devices or drug products (such as a patch that is hard to peel the backing off)
• Product confusion (caused by name, labeling, design or packaging)
• Suspected super potent or sub potent medication
• Labeling problems caused by printing errors/omissions
• Failure to meet performance specifications (including labeling claims) or failure to perform as intended - medical devices

Product Use/ Medication Error:  
Medical Product Use Error: Any report of a product error regardless of patient involvement or outcome. Also report circumstances or events that have the capacity to cause error (e.g., similar product appearance, similar packaging and labeling, sound-alike/look-alike names, etc.).

Product use errors can and do originate in all stages of the medication use system, which includes selecting and procuring drugs, prescribing, preparing and dispensing, administering and monitoring. A product use error is defined as “any preventable event that may cause or lead to inappropriate medical product use or patient harm while the product is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use.”

Medical Device Use Error:  Health care professionals, other caregivers and patients sometimes make errors when using medical devices that can unintentionally cause harm to patients or to themselves. These problems can arise due to problems with the design of the medical device or the manner in which the device is used. Sometimes use errors are noticed and corrected before they can do harm (known as a “close call”). 

Please report device use errors regardless of patient involvement or outcome. Also report circumstances of use or device interactions that could cause or lead to use errors. Medical device use errors can occur for reasons that include the following:

• Device use is inconsistent with the user’s expectations or intuition
• Device use requires physical, perceptual, or cognitive abilities that exceed those of the user
• Devices are used in ways that were not anticipated by the manufacturer
• The device’s labeling or packaging is confusing or inadequate
• The environment adversely affects or influences device use

Problem with Different Manufacturer of Same Medicine:  Any incident, to include, but not limited to, differences in previous therapeutic response, suspected to have resulted from a switch, or change, from one manufacturer to another manufacturer of the same medicine or drug product. This could be changes from a brand name drug product to a generic manufacturer's same product, or from a generic manufacturer's product to the same product as supplied by a different generic manufacturer, or from a generic manufacturer's product to a brand name manufacturer of the same product. 
In order to fully evaluate the incident, please include in Section B5, if available, specific information relative to the switch between different manufacturers of the same medicine, to include, but not limited to, the names of the manufacturers, length of treatment on each manufacturer's product, product strength, and any relevant clinical data including but not limited to the expected clinical response and how it was changed. If you have returned to your prior medication, please note if the prior therapeutic response has returned.
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B2 :    Outcome Attributed to Adverse Event: Indicate all that apply to the reported event:
Death: Check only if you suspect that the death was an outcome of the adverse event, and include the date if known.
Do not check if:

• The patient died while using a medical product, but there was no suspected association between the death and the use of the product.
• A fetus is aborted because of a congenital anomaly (birth defect), or is miscarried.

Life-threatening: Check if you suspect 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): Check if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Do not check if:

• A patient in the hospital received a medical product and subsequently developed an otherwise non-serious adverse event, unless the adverse event prolonged the hospital stay.

Do check if:

• A patient is admitted to the hospital for one or more days, even if released on the same day.
• An emergency room visit results in admission to the hospital.

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: Check if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions. Such would be the case if 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 Defects: Check 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: Check 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 or Important Medical Events: Check when the event does not fit the other outcomes, but the event could have jeopardized the patient and could have required 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.
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B3 :    Date of Event
Provide the actual or best estimate of the date of first onset of the adverse event. If day is unknown, month and year are acceptable. If day and month are unknown, year is acceptable.

• When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child.
• When a fetus is aborted because of a congenital anomaly, or is miscarried, the event onset date is the date pregnancy is terminated.

If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.
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B4 :    Date of this Report
The date the report is filled out.
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B5 :    Describe Event, Problem or Product Use/Medication Error
For an adverse event: Describe the event in detail, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and if relevant, include synopses of any office visit notes or the hospital discharge summary.
To save time and space (and if permitted by your institution), please attach copies of these records with any confidential information deleted. Do not identify any patient, physician, or institution by name. The reporter's identity should be provided in full in Section G.

Information as to any environmental conditions that may have influenced the event should be included, particularly when (but not exclusive to) reporting about a device.

• Results of relevant tests and laboratory data should be entered in block B6. (See instructions for B6).
• Preexisting medical conditions and other relevant history belong in block B7. Be as complete as possible, including time courses for preexisting diagnoses (see instructions for B7).

If it is determined that reuse of a medical device labeled for single use might have caused or contributed to an adverse patient outcome, please report in block B5 the facts of the incident and the perceived contribution of reuse to the occurrence.

If the adverse event involves a human cell, tissue, and cellular and tissue-based product (HCT/Ps), include the following information:  diagnosis/condition for which the HCTP was implanted, the type of surgical procedure and anatomical site of implantation, and the date of onset of symptoms.

For adverse events occurring in donors of whole blood or blood components, please indicate that the adverse event occurred in a donor and the procedure for donation (e.g., apheresis, phlebotomy).

For a product problem: Describe the problem (quality, performance, or safety concern) in sufficient detail so that the circumstances surrounding the defect or malfunction of the medical product can be understood.

• If available, the results of any evaluation of a malfunctioning device and, if known, any relevant maintenance/service information should be included in this Section.
• For a medication, food, cosmetic  or special nutritional product problem, please indicate if you have retained a sample that would be available to FDA.

For a product use error: (see B1 above): Describe the sequence of events leading up to the error in sufficient detail so that the circumstances surrounding the error can be understood. 

For Medication Use Errors: Include a description of the error, the type of staff involved, the work environment in which the error occurred, indicate causes or contributing factors to the error, location of the error, names of the products involved (including the trade (proprietary) and established (proper) name, manufacturer, dosage form, strength, concentration, and type and size of container.

For Medical Device Use Errors: Include a description of the device use error, the type of staff involved, the work environment in which the error occurred, and the circumstances or events that led to or contributed to the use errors.  Medical device use errors can occur for reasons that include the following:

• Device use is inconsistent with the user’s expectations or intuition,
• Device use requires physical, perceptual, or cognitive abilities that exceed those of the user,
• Devices are used in ways that were not anticipated by the manufacturer,
• The device’s labeling or packaging is confusing or inadequate,
• The environment adversely affects or influences device use

For a problem with a different manufacturer of the same medicine (see B1 above): Please include specific information relative to the switch between different manufacturers of the same medicine, to include, but not limited to, the names of each manufacturer, length of treatment on each manufacturer's product, product strength, dosing regimen and any relevant clinical data.
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B6:    Relevant Tests/Laboratory Data, Including Dates
Please provide all appropriate information, including relevant negative test and laboratory findings, in order to most completely convey how the medical work-up/ assessment led to strong consideration of medical product-induced disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.

Please include:

• Any relevant baseline laboratory data prior to the administration or use of the medical product.
• All laboratory data used in diagnosing the event.
• Any available laboratory data/engineering analyses (for devices) that provide further information on the course of the event.

If available, please include:

• Any pre- and post-event medication levels and dates (if applicable).
• Synopses of any relevant autopsy, pathology, engineering, or lab reports.

If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. Do not identify any patient, physician or institution by name. The initial reporter's identity should be provided in full in Section G.
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B7:    Other Relevant History, Including Preexisting Medical Conditions
Knowledge of other risk factors can help in the evaluation of a reported adverse event. For example, if available, provide information on:

• Other known conditions in the patient, e.g.,
  • Hypertension (high blood pressure)
  • Diabetes mellitus
  • Liver or kidney problems
  • Pre-existing infection (in recipients of human cell and tissue products)
• Significant history
  • Allergies 
  • Pregnancy history
  • Smoking and alcohol use, drug abuse
  • Setting

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