FDA Adverse Event
Injury
Summary report: N
TAMPAX TAMPONS SATIN TOUCH SUPER
MDR report key: 108031
·
Received July 25, 1997
Report
- Report Number
- 1217220-1997-00012
- Event Type
- Injury
- Date Received
- July 25, 1997
- Date of Event
- March 21, 1997
- Report Date
- July 21, 1997
- Manufacturer
- TAMBRANDS, INC.
- Product Code
- HEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
REC'D CORRESPONDENCE FROM PARENT WHO STATED HER DAUGHTER WAS TREATED FOR A VAGINAL LACERATION ATTRIBUTED TO THE USE OF A PLASTIC APPLICATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAMPAX TAMPONS SATIN TOUCH SUPER | TAMPONS | HEB | TAMBRANDS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization| L |