Introduction
FDA requires a documented process for all drugs (pharmaceutical and over-the-counter) to ensure that consumers have a way to submit any unanticipated reaction to using or taking the drug. The FDA considers Hand Sanitizer an over-the-counter drug.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
What is an Adverse Event?
Any undesirable event that is associated with the use of a drug or biological product in humans whether or not considered product-related by the applicant. For example rash, burns, skin peeling, skin cracking, redness, etc.
An undesirable event may also be associated with the use of disposable cleaning wipes. These products are not the same as drug products and are regulated differently. While the event is not required to be reported to the FDA, please obtain the information so Advantus may record the event.
What are Adverse Event reporting requirements?
Medical Device Products
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specifies that reports be filed on the FDA’s Medwatch Form 3500A or an electronic equivalent.
Manufacturers
Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
| REPORTER | WHAT TO REPORT | REPORT FORM # | TO WHOM | WHEN |
|---|---|---|---|---|
| Manufacturers | 30-day reports of deaths, serious injuries, and malfunctions | Form FDA 3500A * | FDA | Within 30 calendar days of becoming aware of an event |
| 5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health | Form FDA 3500A * | FDA | Within 5 workdays of becoming aware of an event |
Importers
Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
| REPORTER | WHAT TO REPORT | REPORT FORM # | TO WHOM | WHEN |
| Importers | Reports of deaths and serious injuries | Form FDA 3500A * | FDA and the manufacturer | Within 30 calendar days of becoming aware of an event |
| Reports of malfunctions | Form FDA 3500A * | Manufacturer | Within 30 calendar days of becoming aware of an event |
Drug/Biologic product
What information is required to report an Adverse Event?
A Customer Report/Feedback form is linked to a medical device report event with documented assessment and decision to report the adverse event to a regulatory authority.
- The patient
▪ Patient identifier
● Note: Do NOT use any personally identifiable information. Use their initials instead of their name. DO NOT get any sensitive data such as SSN.
▪ Age/DOB
▪ Gender
▪ Weight
▪ Ethnicity or race - The product used
▪ Picture of product and bottle if possible
▪ Batch date or date of manufacture - The specific adverse event
▪ Outcome attributed to the adverse event, e.g. What happened? What is the complaint? - Description of event
▪ Date of event
▪ Date of the report of Adverse Event - Any other relevant history including pre-existing medical conditions
How is an Adverse Event reported to the FDA?
Medical Device
More information on how to submit MDRs electronically is available on the eMDR website.
- Guidance for Industry, User Facilities, and FDA Staff: eMDR – Electronic Medical Device Reporting
- Final Rule on Electronic Medical Device Reporting (eMDR)
Drug/Biologic product
Events meeting reportable criteria for drug products must be submitted to the FDA using the FDA Form 3500 at the following website:
https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting
How does a consumer submit an Adverse Event?
Customers may report adverse events via phone, email, or www.advantus.com. The product label MUST include the name and contact information of the manufacturer. Contact information can be either email or phone. Email must be a separate email domain that is advertised on the hand cleanser bottles, e.g. “www.advantus.com”. A dedicated phone number must be used; it cannot be the general phone number but it could be an extension. Compliance or Customer Service will check this email and/or phone number to ensure a proper response time. A record of all information gathered from the Adverse Event report will be maintained for 10 years. Reports will be monitored monthly during the monthly compliance meeting.
CFSAN Adverse Event Reporting System (CAERS) Database
The CFSAN Adverse Event Reporting System (CAERS) Database is a database that contains information on adverse events and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN’s safety surveillance program. FDA provides raw data extracted from the CAERS database. The data files, which are available in ASCII format, include:
- demographic and administrative information and the CAERS report ID number;
- product information from the case reports;
- symptom information from the reports;
- patient outcome information from the reports.