FDA Adverse Event
Injury
Summary report: N
FRESH DAYS REGULAR UNSCENTED TAMPONS
MDR report key: 251682
·
Received November 30, 1999
Report
- Report Number
- 2515444-1999-00040
- Event Type
- Injury
- Date Received
- November 30, 1999
- Date of Event
- October 1, 1999
- Report Date
- November 30, 1999
- Manufacturer
- PLAYTEX PRODUCTS, INC.
- Product Code
- HEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RECEIVED A CONSUMER REPORT INFORMING THE CO THAT SHE REQUIRED MEDICAL TREATMENT AFTER EXPERIENCING ITCHING AND BURNING DURING/AFTER HER MENSES. CONSUMER INDICATED HER DOCTOR REMOVED LITTLE PIECES OF COTTON AND FURTHER ADVISED THAT HER EXPERIENCE WAS DUE TO THE "RESIDUE OF TAMPONS".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FRESH DAYS REGULAR UNSCENTED TAMPONS | TAMPON | HEB | PLAYTEX PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |