REPORTING ADVERSE EVENTS

Patient/Caregiver, please contact your doctor immediately.

For Physicians

Please submit the attached form when reporting an adverse event.

Form FDA 3500 - Voluntary Reporting
For use by healthcare professionals, consumers, and patients.

Form FDA 3500A - Mandatory Reporting
For use by IND reporters, manufacturers, distributors, importers, user facilities personnel

Adverse event: Any incident where the use of a medication (drug or biologic, including HCT/P), at any dose, 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.

Other relevant history including preexisting medical conditions and knowledge of other risk factors can help in the evaluation of a reported adverse event. If available, provide information on:
Other known conditions in the patient, e.g.,

• Hypertension (high blood pressure)
• Diabetes mellitus
• Liver or kidney problems
• Significant history
• Race
• Allergies
• Pregnancy history
• Smoking and alcohol use, drug abuse
• Setting

Please limit your submissions to those events that are serious. An event is classified as serious when the Patient Outcome 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

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
• Defective components
• Therapeutic failures (product didn't work)
• Product confusion (caused by name, labeling, design or packaging)
• Suspected superpotent or subpotent medication
• Labeling problems caused by printing errors/omissions

Product Use Error:
Medication Use Error: Any report of a medication 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.). Medication 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 medication error is defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication 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."