MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-06-19 for FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN manufactured by Procter & Gamble Manufacturing Co..
[5846911]
Profound and permanent neurological injuries [nervous system disorder]. Severe and permanent physical injuries [injury]. Hypocupremia [copper deficiency]. Hyperzinczemia [hyperzincaemia]. Myleoneuropathy [myelopathy]. Zinc poisoning [metal poisoning]. Case description: an attorney reported that their male client, currently age (b)(6) years, used fixodent denture adhesive, form/version unknown, unspecified total daily use, as intended to hold dentures that he received approximately 15 years ago, and reported the following: hypocupremia, zinc poisoning, hypezinczemia, and myleoneuropathy, profound and permanent neurological injuries, severe and permanent physical injuries, and other injuries which have left him unable to perform his normal, customary and daily activities. Treatment: has received and will continue to receive unspecified medical care. The case outcome was not recovered/not resolved. Past medical history included: medical history - received dentures approximately 15 years ago. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13475987]
Lot number or product was not provided by the reporter and case concerns long-term product use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530449-2015-00005 |
| MDR Report Key | 4856847 |
| Report Source | 00 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-22 |
| Date Mfgr Received | 2015-05-22 |
| Date Added to Maude | 2015-06-19 |
| 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 | ATTORNEY |
| 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 | 2015-06-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other | 2015-06-19 |