FDA Adverse Event
Injury
Summary report: N
TAMPER PEARL
MDR report key: 476290
·
Received July 21, 2003
Report
- Report Number
- MW4003538
- Event Type
- Injury
- Date Received
- July 21, 2003
- Report Date
- June 16, 2003
- Manufacturer
- TAMBRANDS, INC.
- Product Code
- HEB
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
FAMILY MEMBER STATED THAT THE PT HAD DIFFICULTY REMOVING ONE OF THE REFERENCED TAMPONS. ANOTHER FAMILY MEMBER STATED THAT THE TAMPON APPEARED TO BECOME ATTACHED TO THE VAGINAL WALL. AS A RESULT, THE REMOVAL WAS VERY DIFFICULT AND SUBSEQUENTLY PT DEVELOPED A LOT OF VAGINAL IRRITATION. FAMILY MEMBER STATED THAT PT WAS TOWARDS THE END OF THEIR CYCLE BUT THAT THE TAMPON HAD ONLY BEEN IN PLACE FOR APPROX 4 HRS. MFR IS NOT AWARE OF ANY OF THIS PRODUCT HAVING MORE THAN THE NORMAL AMOUNT OF COMPLAINTS EXPECTED FOR THIS TYPE OF PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAMPER PEARL | REGULAR TAMPON | HEB | TAMBRANDS, INC. | * | 2239368401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |