FDA Adverse Event
Injury
Summary report: N
TAMPON
MDR report key: 24210645
·
Received January 29, 2026
Report
- Report Number
- MW5183028
- Event Type
- Injury
- Date Received
- January 29, 2026
- Date of Event
- January 23, 2026
- Report Date
- January 23, 2026
- Manufacturer
- TOPCARE TOPCO ASSOCIATES, LLC
- Product Code
- HEB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I WAS USING THE TOPCARE TAMPONS AND AS I WAS REMOVING IT, THE PRODUCT FELL APART, LEAVING MATERIAL STUCK INSIDE. MEDICAL EVALUATION MAY BE NEEDED TO PREVENT INFECTION AND/OR TOXIC SHOCK SYNDROME. WHEN I TRIED TO LOOK UP EXPIRATION AND ALL OTHER REQUIRED INFORMATION, THEIR LINKS WILL NOT WORK! I HAVE NO WAY TO VERIFY THE PRODUCT IS EVEN SAFE! PICTURED BELOW SHOWING THEIR CODE DOES NOT PROVIDE ANY INFO AND NO INFO ON THE BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268053 | TAMPON | TAMPON, MENSTRUAL, UNSCENTED | HEB | TOPCARE TOPCO ASSOCIATES, LLC | 5019.08.04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |