TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT
Report
- Report Number
- 1219109-2025-00361
- 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
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
PRODUCT INVESTIGATION IS IN PROGRESS.
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 |
|---|---|---|---|---|---|---|---|
| 2603768 | TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 5193243068W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |