FDA Adverse Event
Injury
Summary report: N
PEARL
MDR report key: 490458
·
Received August 20, 2003
Report
- Report Number
- MW4003581
- Event Type
- Injury
- Date Received
- August 20, 2003
- Report Date
- August 20, 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
PT WAS USING THE REFERENCED BRAND OF TAMPON AND WHEN THEY WERE DIAGNOSED AS HAVING TSS. PARENT STATED THAT THE PT BECAME ILL - 5 DAYS INTO CYCLE AND THAT THEY HAD BEEN USING ONLY THIS BRAND OF TAMPON. PARENT STATED THE PT STARTED USING THIS BRAND OF TAMPON 6 OR 7 MONTHS AGO AND THAT NORMALLY THEY USE ONLY TAMPONS DURING THE SUMMER BECAUSE OF THEIR SWIMMING ACTIVITIES. AT OTHER TIMES THEY MAY USE BOTH TAMPONS AND/OR PADS. PARENT STATED THAT THE PT BECAME ILL AFTER THE SUSPECT TAMPON HAD BEEN IN USE FOR - 7 HOURS AND THAT THE TAMPON WAS REMOVED BY THE HOSPITAL STAFF. PARENT ALSO STATED THAT THIS WAS NOT THE FIRST TAMPON USED FROM THE BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEARL | TAMPONS | HEB | TAMBRANDS, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |