MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-27 for FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN manufactured by Procter & Gamble Manufacturing Co..
[6256779]
Poisoned due to zinc [metal poisoning]. Mystery illness [unevaluable event]. Case description: a daughter reported via social media that her mother used fixodent denture adhesive, form/version unknown, amount and frequency unknown, had a mystery illness and died because fixodent poisoned her slowly. The case outcome was fatal. No further information was provided. On 29-jun-2015 consumer relations received follow-up social media post: the daughter clarified this product, fixodent, poisoned her mom and she died a slow death due to the zinc. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13706464]
Lot number and product were not provided by the reporter, therefore, cannot proceed with batch retain testing or product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530449-2015-00008 |
| MDR Report Key | 4943189 |
| Report Source | 04 |
| Date Received | 2015-07-27 |
| Date of Report | 2015-06-29 |
| Date Mfgr Received | 2015-06-29 |
| Date Added to Maude | 2015-07-27 |
| 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 | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2015-07-27 |
| 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 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-07-27 |