MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-02 for PLAYTEX SPORT, MULTIPACK TAMPONS manufactured by Playtex Products, Inc..
[1136554]
Rec'd a summons and complaint informing us in 2007, claimant became physically sick while using tampons during her menstrual cycle. In 2007, claimant was admitted to a hosp, where her condition deteriorated; wherein she experienced multi-system organ failure until her death in the next day. Summons and complaint informs an autopsy performed determined claimant died from toxic shock syndrome (tss). Please note, the summons and complaint provided limited info regarding claimant's hospitalization, treatment, formal medical diagnosis, secondary diagnoses, etc; and no info provided if claimant had other medical condition(s) that may have contributed to the reported adverse event.
Patient Sequence No: 1, Text Type: D, B5
[8310531]
We have requested the return of product for eval, and date code info for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2009-00006 |
| MDR Report Key | 1462561 |
| Report Source | 07 |
| Date Received | 2009-09-02 |
| Date of Report | 2009-09-02 |
| Date of Event | 2007-08-06 |
| Date Mfgr Received | 2009-08-04 |
| Date Added to Maude | 2009-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET DEPALMA |
| Manufacturer Street | 75 COMMERCE DR |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017858000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX SPORT, MULTIPACK TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2009-09-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX PRODUCTS, INC. |
| Manufacturer Address | 804 WALKER RD DOVER DE 19990 US 19990 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-09-02 |