MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-06-23 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC manufactured by Tambrands Manufacturing, Inc..
[2100295]
Poisoned by product (tampax) [device toxicity]. Case description: a consumer reported via email that he was told by a coroner, his wife has been poisoned by tampax tampons. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9136182]
Lot number was not provided by consumer and product not rec'd to date, therefore, unable to proceed with the product investigation. Procter & gamble (p&g) is submitting this report only because it believes an event that meets the requirements of 21 cfr part 803 may have occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2011-00007 |
| MDR Report Key | 2153031 |
| Report Source | 04 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-06-02 |
| Date Mfgr Received | 2011-06-02 |
| Date Added to Maude | 2012-08-24 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE WINTON HILL BUSINESS CENTER |
| 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 UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2011-06-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2011-06-23 |