MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-07-28 for PLAYTEX SPORT FRESH BALANCE 32 CT MULTIPACK SCENTED REGULAR/SUPER 078300002208 manufactured by Playtex Manufacturing, Inc..
[50715118]
To date, the consumer has not returned the product for evaluation. A review of the device history record for the date code provided confirmed that the device meets specifications.
Patient Sequence No: 1, Text Type: N, H10
[50715119]
Consumer reported that within an hour of using the product she developed a high fever, vomiting and diarrhea, but symptoms subsided upon removal of the product. She sought medical attention two days later but no treatment was prescribed. Consumer reports that "her doctor stated her symptoms were more than likely tss. " consumer added she had symptoms of tss a few years ago but did not seek medical attention at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002515444-2016-00007 |
| MDR Report Key | 5831544 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-07-28 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-06-04 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2016-07-28 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS GALE LYDIC |
| Manufacturer Street | 185 SAULSBURY RD |
| Manufacturer City | DOVER DE 19904 |
| Manufacturer Country | US |
| Manufacturer Postal | 19904 |
| Manufacturer Phone | 3026786429 |
| Manufacturer G1 | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Street | 805 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 FRESH BALANCE 32 CT MULTIPACK SCENTED REGULAR/SUPER |
| Generic Name | MENSTRUAL TAMPON |
| Product Code | HIL |
| Date Received | 2016-07-28 |
| Model Number | 078300002208 |
| Lot Number | 16035CA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Address | 805 WALKER RD DOVER DE 19904 US 19904 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-28 |