MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-09-27 for PLAYTEX SPORT TAMPON manufactured by Playtex Manufacturing, Inc..
[15264390]
(b)(4) became aware that an attorney has filed a lawsuit in the (b)(6) claiming that his client had suffered toxic shock syndrome after using a playtex sport tampon. The complaint alleges that a (b)(6) consumer used a playtex sport tampon on or about (b)(6) 2010, and on (b)(6) 2010, she came down with flu-like symptoms. The complaint further states that on or about (b)(6) 2010, the consumer became increasingly ill and developed other symptoms. It says her parents immediately took the consumer to the emergency room where she was diagnosed with toxic shock syndrome and was admitted to the hospital where she was treated in the intensive care unit for five weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515444-2013-00009 |
| MDR Report Key | 3379100 |
| Report Source | 00,04 |
| Date Received | 2013-09-27 |
| Date Mfgr Received | 2013-08-30 |
| Date Added to Maude | 2013-10-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER REMPE |
| Manufacturer Street | 6 RESEARCH DR. |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2035263120 |
| Manufacturer G1 | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Street | 804 WALKER RD |
| Manufacturer City | DOVER DE 19904 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX SPORT TAMPON |
| Generic Name | PLAYTEX SPORT TAMPON |
| Product Code | HIL |
| Date Received | 2013-09-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Address | DOVER DE 19904 US 19904 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-27 |