MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for PLAYTEX SPORT TAMPONS SUPER PLUS manufactured by .
[37439136]
(b)(6) has been working on a cluster of apparent tampon associated toxic shock cases. Four young women have been hospitalized at a single hospital since the beginning of the year. The girls reside in 3 different local health jurisdictions in the same general area of the state. Playtex sports tampon: super use (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059966 |
| MDR Report Key | 5409522 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-02-01 |
| Date of Event | 2016-01-02 |
| Date Added to Maude | 2016-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX SPORT TAMPONS SUPER PLUS |
| Generic Name | PLAYTEX SPORT TAMPONS SUPER PLUS |
| Product Code | HIL |
| Date Received | 2016-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-02-01 |