MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-25 for SPORT TAMPONS SUPER UNSCENTED manufactured by Playtex Manufacturing Inc..
[4243894]
Mother of pt reported her (b)(6) daughter was diagnosed with toxic shock syndrome. On (b)(6) 2014, daughter developed chills, anxiousness, disorientation and a fever of 104 degrees. She was taken to a medical center by ambulance and diagnosed with tss. She was hospitalized until (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515444-2014-00003 |
| MDR Report Key | 3676757 |
| Report Source | 04 |
| Date Received | 2014-02-25 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-01-21 |
| Date Mfgr Received | 2014-01-27 |
| Date Added to Maude | 2014-03-14 |
| 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 MARTIN REMPE |
| Manufacturer Street | 6 RESEARCH DR. |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPORT TAMPONS SUPER UNSCENTED |
| Generic Name | MENSTRUAL TAMPON, UNSCENTED |
| Product Code | HIL |
| Date Received | 2014-02-25 |
| Lot Number | 13330W |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING INC. |
| Manufacturer Address | DOVER DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-02-25 |