FDA Adverse Event
Malfunction
Summary report: N
TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT
MDR report key: 22077525
·
Received May 23, 2025
Report
- Report Number
- 1219109-2025-00156
- Event Type
- Malfunction
- Date Received
- May 23, 2025
- Report Date
- July 1, 2025
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- UDI-DI
- 00073010713383
- PMA / PMN Number
- K081555
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION
Additional Manufacturer Narrative · 0
PRODUCT INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 0
RIPPED INSIDE ME...HAD TO DIG OUT PIECES OF THE TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON RIPPED INSIDE ME- TAMPAX [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON RIPPED INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
Description of Event or Problem · 0
RIPPED INSIDE ME...HAD TO DIG OUT PIECES OF THE TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON RIPPED INSIDE ME- TAMPAX [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON RIPPED INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2367434 | TAMPAXTAMPONSPEARLFULLSIZEMIXEDUNSCNT34CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 424815052T | 00073010713383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female |