MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-17 for GG 360 TAMPONS REGULAR UNSCENTED manufactured by Playtex Manufacturing, Inc..
[20360206]
An email was received by a consumer stating she was diagnosed with tss after using platex tampons. She was hospitalized for 4 days and was currently on 14 days of in-home iv medication.
Patient Sequence No: 1, Text Type: D, B5
[20480892]
(b)(4) is submitting this report only because an event meeting the requirements of 21 cfr 803 may have occurred. This does not mean that (b)(4) believes the product malfunctioned or that an (b)(4) product was, in fact, associated with an actual consumer injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2014-00002 |
| MDR Report Key | 3592962 |
| Report Source | 07 |
| Date Received | 2014-01-17 |
| Date of Report | 2014-01-20 |
| Date of Event | 2013-12-10 |
| Date Mfgr Received | 2013-12-22 |
| Date Added to Maude | 2014-01-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER REMPE |
| Manufacturer Street | 6 RESEARCH DRIVE |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer G1 | PLAYTEX PRODUCTS, INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GG 360 TAMPONS REGULAR UNSCENTED |
| Generic Name | MENSTRUAL TAMPON UNSCENTED |
| Product Code | HIL |
| Date Received | 2014-01-17 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-01-17 |