MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-31 for PLAYTEX TAMPONS REGULAR manufactured by Playtex International.
[20840067]
Toxic shock syndrome from using playtex regular absorbency scented tampon. Admitted to hospital with dehydration, vomiting, 103. 2 temperature and kidney failure. Within 24 hours, had adult respiratory distress syndrome, sepsis, rash, and began having heart failure. This proved to be fatal. Dose or amount: 1 tampon. Frequency: 4 to 6 hours. Route: vag. Dates of use: (b)(6) 2010. Diagnosis or reason for use: menstrual cycle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018790 |
| MDR Report Key | 1950716 |
| Date Received | 2010-12-31 |
| Date of Report | 2010-12-31 |
| Date of Event | 2010-06-11 |
| Date Added to Maude | 2011-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX TAMPONS REGULAR |
| Generic Name | PLAYTEX TAMPONS |
| Product Code | HIL |
| Date Received | 2010-12-31 |
| ID Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2010-12-31 |