TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT
Report
- Report Number
- 1219109-2025-00359
- Event Type
- Malfunction
- Date Received
- December 9, 2025
- Report Date
- December 12, 2025
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K081555
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT INVESTIGATION IS IN PROGRESS.
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
HURTS, VAGINA (VULVOVAGINAL PAIN). PULLING TAMPON STRING AND SCRAPING MY PRIVATES, VAGINA (VULVOVAGINAL INJURY). TAMPONS ARE IN THE TUBE UPSIDE DOWN, TAMPAX PEARL (DEVICE PHYSICAL PROPERTY ISSUE). WHEN I GO TO PULL IT OUT, IT HURTS. PULLING THE TAMPON STRING AND SCRAPING PRIVATES (COMPLICATION OF DEVICE REMOVAL). CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS ARE IN THE TUBE UPSIDE DOWN. NO SERIOUS INJURY WAS REPORTED.
HURTS - VAGINA [VULVOVAGINAL PAIN]. PULLING TAMPON STRING AND SCRAPING MY PRIVATES- VAGINA [VULVOVAGINAL INJURY]. TAMPONS ARE IN THE TUBE UPSIDE DOWN- TAMPAX PEARL [DEVICE PHYSICAL PROPERTY ISSUE] . WHEN I GO TO PULL IT OUT, IT HURTS... PULLING THE TAMPON STRING AND SCRAPING PRIVATES [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPONS ARE IN THE TUBE UPSIDE DOWN. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2590597 | TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 5193243042W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |