Facilities are required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient or employee of the facility.
The FDA receives voluntary reports on other serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that facilities suspect is associated with the use of an FDA-regulated drug, biologic, dietary supplement or cosmetic.
FDA has defined a device user facility as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility. A user facility subject to MDR may be either an independent entity or operated by another medical entity.
ASAP but no later than 10 working days for individual events.
By January 1 of each year for the annual report.
For individual events, facilities should report to the FDA and the device manufacturer in case of deaths; or to the device manufacturer in case of serious injury.
Visit the MedWatch website to report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated medical device (required) or with the use of an FDA-regulated drug, biologic, dietary supplement or cosmetic (recommended). You can also report suspected counterfeit medical products to FDA through MedWatch.
Reports can also be made by postage-paid Form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf), by fax (1-800-FDA-0178), or by calling 1-800-FDA-1088 to request a reporting form.
For the annual report, use the Medical Device Reporting Annual User Facility Report.
Q&A on the FDA's Adverse Event Reporting System (FAERS): https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers
The Safe Medical Devices Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (FDCA). It is federal legislation which was designed so that the FDA could quickly be informed of any medical product that has caused or suspected to have caused a serious illness, injury or death. The FDA will then take immediate action to track and/or recall the product for further action. This law was passed to protect the public.
Safe Medical Devices Act, 21 USC 360i(b), 21 CFR Part 803
Subpart C—User Facility Reporting Requirements
§803.30 If I am a user facility, what reporting requirements apply to me?
(a) You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows:
(1) Reports of death. You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by §803.32. Reports sent to the Agency must be submitted in accordance with the requirements of §803.12(b).
(2) Reports of serious injury. You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by §803.32. Reports sent to the Agency must be submitted in accordance with the requirements of §803.12 (b).
(b) What information does FDA consider “reasonably known” to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.
§803.33 If I am a user facility, what must I include when I submit an annual report?
(a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year.
Note: Facilities should watch for mandated reporting on certain medications for which an Emergency Use Authorization (EUA) has been issued for COVID-19. This happened with the EUA for hydroxychloroquine and chloroquine; however, that EAU was revoked in June of 2020.
See also: Contaminated Drugs, Devices, Or Biologics - Death/Serious Injury (Sentinel Event 2A)
See also: Device Failure - Death/Serious Injury (Sentinel Event 2B)
