MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2013-10-14 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[3880760]
Toxic shock syndrome. Case description: a consumer reported that her daughter, age unspecified, used tampax tampon, version/absorbency/scent unk tampon for the first time and died of toxic shock syndrome on (b)(6) 2013. The case outcome was fatal. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[11160175]
Lot number or product was not provided by the reporter therefore unable to proceed with batch retain testing or product investigation. Reason that the device has not been evaluated by the mfr: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2013-00008 |
| MDR Report Key | 3415383 |
| Report Source | 01,04 |
| Date Received | 2013-10-14 |
| Date of Report | 2013-10-08 |
| Date Mfgr Received | 2013-10-08 |
| Date Added to Maude | 2013-10-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Street | 2879 HOTEL RD. |
| Manufacturer City | AUBURN ME 04210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2013-10-14 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-10-14 |