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October 11, 2007
Posted: October 11, 2007
Form FDA 3500A (PDF format) is a two-sided form. It is for use by user facilities, distributors, importers, applicants, and manufacturers for MANDATORY reporting of adverse events and product problems associated with drugs, biologics, and devices, as designated in the applicable statutes and FDA regulations. In addition, MedWatch Form 3500A is for use by manufacturers, packers and distributors for MANDATORY reporting of serious adverse events associated with the use of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462).
http://www.fda.gov/MedWatch/getforms.htm
http://www.cfsan.fda.gov/~dms/dsaerins.html
At this time, FDA requires that mandatory reports using MedWatch Form 3500A for serious adverse events associated with the use of dietary supplements be submitted in hard copy by mail only (see #5 for address). FDA does not currently accept dietary supplement serious adverse event reports electronically or by facsimile.
For Dietary Supplements Only:
Food and Drug Administration
Center for Food Safety and
Applied Nutrition
Office of Food Defense, Communication and Emergency Response
CAERS Team (HFS-11)
5100 Paint Branch Parkway
College Park, MD 20740
Office of Nutrition,
Labeling, and Dietary Supplements
Center for Food Safety
and Applied Nutrition
Food and Drug
Administration
5100 Paint Branch
Parkway, HFS-800
College Park, MD 20740
(301) 436-2375
At the top of the front page
Enter the page number and total number of pages submitted (include attachments in the total) where the words Page __ of __ are indicated.
On the top-right corner of the front page, enter the manufacturer report number, packer report number or distributor report number in the "Mfr Report #" box. Enter all report numbers, if applicable, to cross-reference this report with a report from another source on the same event. The manufacturer, packer, or distributor report number is the unique identifier used by the manufacturer, packer or distributor for this report. The manufacturer, packer or distributor report number is also entered in block G9 on the back of the form.
The patient is the person who experienced the adverse event (referred to in these instructions as the "injured person"). If more than one person experienced the adverse event, complete a separate form for each injured person.
Parent-child/fetus report(s) are those cases in which either a fetus/breast feeding infant or the mother, or both, sustain an adverse event that the initial reporter considers possibly associated with a product administered to the mother during pregnancy. Several general principles are used for filing these reports:
Provide the injured person’s initials or some other type of identifier that will allow both the responsible person and the initial reporter (if different) to locate the case if contacted for follow-up. Do not use the injured person's name or social security number.
The injured person's identity is held in strict confidence by FDA and protected to the fullest extent of the law.
Provide the most precise information available. Enter the injured person’s birthdate, if known, or the injured person's age at the time of event onset. For age, indicate time units used (e.g., years, months, and days).
Enter the injured person’s gender. If the adverse event is a congenital anomaly or birth defect, report the sex of the child.
Enter the injured person’s weight. Indicate whether the weight is in pounds (lbs.) or kilograms (kgs). Make a best estimate if exact weight is unknown.
Choose the appropriate box. For dietary supplements, product problems should be reported to FDA on Form 3500A only if the problem may have caused or contributed to a serious adverse event. In that case, both boxes should be checked. Dietary supplement product problems not associated with a serious adverse event may be reported to FDA on Form FDA 3500, the MedWatch voluntary reporting form.
Adverse event: Any adverse health-related event associated with the use of a dietary supplement. Report only serious adverse events to FDA on Form 3500A. See instructions for block B2, below, for the definition of a serious adverse event.
Product problem (e.g., defects): Any report regarding the quality or safety of any dietary supplement.
Dietary Supplements: Serious adverse events associated with the use of a dietary supplement must be reported to FDA. A serious adverse event, as defined in Section 761(a)(2) of the Federal Food, Drug, and Cosmetic Act, means an adverse event that:
Indicate ALL outcomes that apply to the reported event:
Death: Check if death was an outcome of the adverse event, or if the cause of the death is unknown. Include the date of death, if known.
DO NOT check if:
Life-threatening: Check if it is suspected that:
Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a result of the serious adverse event.
Do NOT check if:
Do check if:
Note: Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., death, life-threatening experience, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or intervention required to prevent one of these outcomes)
Disability or Permanent Damage: Check if the serious adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions (i.e, a persistent or significant disability or incapacity).
Congenital Anomaly/Birth Defect: Check if it is suspected that exposure to a dietary supplement prior to conception or during pregnancy may have resulted in a congenital anomaly or birth defect in the child.
Required Intervention to Prevent Permanent Impairment/Damage (Devices): Not applicable for dietary supplements. This box is for device adverse event reporting only.
Other Serious (Important Medical Events):
Check if, based on reasonable medical judgment, the adverse event required a medical or surgical intervention to prevent one of the following outcomes:
Provide the actual date or best estimate of the date of first onset of the serious adverse event. If day is unknown, month and year are acceptable. If day and month are unknown, year is acceptable.
If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.
The date the report is filled out.
For a serious adverse event: Describe the event in detail using the initial reporter's own words, 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 the institution), attach copies of these records with any confidential information deleted. DO NOT identify any injured person, physician, or institution by name. The initial reporter's identity should be provided in full in section E.
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 the date diagnosed and duration of the preexisting medical condition (see instructions for B7).
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 dietary supplement-induced disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.
Include:
If available, include:
If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. DO NOT identify any injured person, physician or institution by name. The initial reporter's identity should be provided in full in section E.
If available, provide information on:
For adverse event reporting, a suspect product is one that the initial reporter suspected was associated with the adverse event. In block C10 enter other concomitant products (other dietary supplements, drugs, biologics, or medical devices) that the injured person was using at the time of the event but that are NOT thought by the initial reporter to be involved in the event.
Up to two (2) suspect products may be reported on one form (#1="first" suspect product, #2="second" suspect product). Attach an additional form if there were more than two suspect products for the reported serious adverse event.
Use the product or trade name as marketed in the U.S.
Describe how the product was used by the injured person (e.g., one tablet four times a day). For reports involving overdoses, the amount of product used in the overdose should be listed, NOT the amount recommended in the directions on the product label.
The therapy dates are the dates during which the dietary supplement was consumed.
Provide the date the injured person started taking the dietary supplement (or best estimate) and the date use was stopped (or best estimate). If no dates are known, an estimated duration is acceptable (e.g., 2 years) or, if usage was less than one day, then describe when the dietary supplement was taken (e.g., 1 gelcap at 5 p.m.).
Give the reason(s) why the injured person used the product.
In addition to checking the appropriate box, provide supporting information, lab tests, and dates, if available, in block B6.
If known, include the lot number of the suspect dietary supplement.
Include the expiration date of the suspect dietary supplement.
In addition to checking the appropriate box, provide supporting information, lab tests, and dates, if available, in block B6.
If the product has a unique or distinct identification code, such as a Universal Product Code (UPC) number, provide the identification code here.
List and provide dates of use for any other dietary supplements, drugs, biologics, or medical devices that the injured person was taking or using at the time of the serious adverse event. Do not include products used to treat the serious adverse event.
Please provide the name, mailing address, and phone number of the person who initially reported the serious adverse event to the dietary supplement manufacturer, packer or distributor, and who can be contacted to provide information on the adverse event if follow-up is necessary. If available, provide the initial reporter's e-mail address and fax number. If the initial reporter has requested that his/her name and contact information not be provided to FDA, enter "Requested Anonymity" in block E1.
Indicate whether or not the initial reporter is a health professional (e.g., physician, pharmacist, nurse, etc.). If not a health professional, complete block E3 by filling in NA.
Indicate the initial reporter's occupation (type of health professional, if applicable, or "NA" for non-health professionals). For health professionals, include specialty if appropriate.
Indicate whether the initial reporter also reported the serious adverse event to FDA.
At the top of the back page, enter the page number and total number of pages submitted (include attachments in the total) where the words Page __ of __ are indicated.
This section is to be filled out by the dietary supplement manufacturer, packer or distributor submitting the serious adverse event report to FDA.
Enter the full name and address of the manufacturer, packer or distributor reporting site [contact office], including contact name.
Enter the telephone number of the contact office or a representative knowledgeable about the serious adverse event report.
Check the box(es) that most accurately describe(s) how the manufacturer, packer or distributor [contact office] became aware of the reported serious adverse event or from where the information about the serious adverse event originated.
This means the date when the responsible person (i.e., the manufacturer, packer or distributor whose name is listed on the label of the dietary supplement associated with the serious adverse event) receives the minimum data elements (i.e., identifiable injured person, initial reporter, suspect dietary supplement, serious adverse event) to submit a serious adverse event report to FDA.
For dietary supplement serious adverse event reports that a manufacturer, packer or distributor is submitting for the first time, check the "15-day" box and the "Initial" box. As specified in Section 761(c)(1) of the Federal Food, Drug, and Cosmetic Act, serious adverse event reports associated with the use of a dietary supplement must be submitted to FDA no later than 15 business days after the report is received through the address or phone number on the label of the product. If the report is received through other means, it should still be submitted to FDA within 15 business days.
Because FDA recommends that follow-up reports of new medical information related to a dietary supplement adverse event report be submitted by attaching a photocopy of the initial serious adverse event report to the new medical information, rather than by completing a new Form 3500A, the "follow-up" box does not apply to dietary supplements.
For all manufacturers, packers and distributors:
Enter the Manufacturer, Packer, or Distributor report number exactly as it appears in the "Mfr Report #" field in the upper right corner of the first page.