FDA Adverse Event
Injury
Summary report: N
TAMPAX TAMPONS
MDR report key: 108022
·
Received July 25, 1997
Report
- Report Number
- 1217220-1997-00013
- Event Type
- Injury
- Date Received
- July 25, 1997
- Date of Event
- October 1, 1996
- Report Date
- July 21, 1997
- Manufacturer
- TAMBRANDS INC.
- Product Code
- HEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
PARENT CALLED AND STATED HER DAUGHTER WAS DIAGNOSED AS HAVING TOXIC SHOCK SYNDROME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAMPAX TAMPONS | TAMPONS | HEB | TAMBRANDS INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Life Threatening |