FDA Adverse Event
Injury
Summary report: N
TAMPAX TAMPONS
MDR report key: 1202346
·
Received October 13, 2008
Report
- Report Number
- MW5008652
- Event Type
- Injury
- Date Received
- October 13, 2008
- Date of Event
- June 3, 2008
- Report Date
- October 13, 2008
- Manufacturer
- PROCTOR AND GAMBLE
- Product Code
- HEB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WAS HAVING MY PERIOD AND I INSERTED MY TAMPAX TAMPON AS I NORMALLY WOULD DO. I WAS HAVING ISSUES WITH IT STAYING IN AND I REALIZED IT WAS BECAUSE THERE WAS A SILICAL GEL DESICCANT, THAT WAS PLASTIC AND CYLINDRICAL IN SHAPE, THAT WAS LODGED IN MY VAGINA. THE DESICCANT APPARENTLY WAS ON TOP OF MY TAMPON BUT HIDDEN INSIDE THE APPLICATOR BECAUSE I DIDN'T SEE IT DURING INSERTION. I REALIZED WHAT IT WAS THE FOLLOWING MORNING WHEN THE DESICCANT FINALLY FELL OUT OF ME DURING MY MORNING URINATION. THAT EVENING I HAD TO SLEEP WITH A MAXI PAD. I ENDED UP WITH A YEAST INFECTION AND A SERIOUS FEAR OF TAMPONS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: MENSTRUAL CYCLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAMPAX TAMPONS | MULTI PAX CARDBOARD TAMPONS | HEB | PROCTOR AND GAMBLE | MULTI PAX | 7192243099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |