FDA Adverse Event
Injury
Summary report: N
EQUATE TAMPON WITH COMPACT PLASTIC APPLICATOR
MDR report key: 12325086
·
Received August 13, 2021
Report
- Report Number
- MW5103260
- Event Type
- Injury
- Date Received
- August 13, 2021
- Date of Event
- August 11, 2021
- Report Date
- August 12, 2021
- Manufacturer
- WAL-MART STORES, INC.
- Product Code
- HEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
TAMPON UNRAVELS INSIDE UPON PULLING IT OUT. THIS HAPPENED MULTIPLE TIMES. IT FELL APART INTO AT LEAST 3 PIECES. MULTIPLE REVIEWS ONLINE HAVE STATED THE SAME THING. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1214700 | EQUATE TAMPON WITH COMPACT PLASTIC APPLICATOR | TAMPON, MENSTRUAL, UNSCENTED | HEB | WAL-MART STORES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R |