FDA Adverse Event
Malfunction
Summary report: N
TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN
MDR report key: 23580941
·
Received November 18, 2025
Report
- Report Number
- 1219109-2025-00331
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Report Date
- November 10, 2025
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K081555
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.
Description of Event or Problem · 0
PQC: PRODUCT OR COMPONENT; RETAINED IN BODY...STRING OF THE TAMPON APPEARED AND THEN I DID GO TO THE DOCTOR AND THEY TOOK IT OUT- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] PQC: CORD; DETACHED, UNRAVELED, COMING APART....TAMPON'S STRING WAS TORN [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT SHE HAD TO GO TO THE DOCTOR TO REMOVE A TAMPON A FEW YEARS AGO. NO SERIOUS INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2317034 | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |