FDA Adverse Event
Death
Summary report: N
KOTEX SECURITY TAMPONS
MDR report key: 311714
·
Received January 11, 2001
Report
- Report Number
- 2381757-2001-00001
- Event Type
- Death
- Date Received
- January 11, 2001
- Date of Event
- March 17, 2000
- Report Date
- January 11, 2001
- Manufacturer
- KIMBERLY-CLARK CORPORATION/CONSUMER PRODUCTS MILL
- Product Code
- HEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
KIMBERLY-CLARK REC'D NOTICE ON 12/12/00 ALLEGING THAT IN 2000, PT EXPERIENCED DIARRHEA, VOMITING, HEADACHE, DECREASED URINATION, FEVER, HYPOTENSION AND A SUNBURN LIKE RASH. PT WAS HOSPITALIZED IN 2000 AND DIAGNOSED WITH TOXIC SHOCK SYNDROME. THE FOLLOWING MONTH, PT DIED. PT WAS ALLEGEDLY USING KORTEX SECURITY TAMPONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1171 | KOTEX SECURITY TAMPONS | UNSCENTED MENSTRUAL TAMPON - SIZE UNKNOWN | HEB | KIMBERLY-CLARK CORPORATION/CONSUMER PRODUCTS MILL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| H| L| R| S |