MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-10 for FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR manufactured by Procter & Gamble Manufacturing Co..
[47163712]
Product was not provided by the reporter and case concerns long term product use.
Patient Sequence No: 1, Text Type: N, H10
[47163713]
Muscle deterioration [muscle atrophy], neuropathy [neuropathy peripheral], tingling - both feet and hands [paraesthesia], numbness - both feet [hypoaesthesia], pain [pain]. Case description: the consumer, a (b)(6) old male, was using fixodent adhesive original cream no flavor, once a day for 12 years. He was diagnosed with neuropathy 12 years ago. He reported the additional symptoms beginning 12 years ago: muscle deterioration, tingling in hands and both feet, numbness in both feet, and pain. Treatment: unspecified pain medication. He was tested for diabetes and was considered to be pre-diabetic. He stated that the neuropathy had taken over his life. The consumer was on disability. He was concerned that his symptoms were caused by zinc in the fixodent. It was planned to have his blood zinc level tested. He stopped using the product on (b)(6) 2016. The case outcome was not recovered/not resolved. Allergies: none. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2016-00005 |
| MDR Report Key | 5717960 |
| Report Source | CONSUMER |
| Date Received | 2016-06-10 |
| Date of Report | 2016-05-13 |
| Date Mfgr Received | 2016-05-13 |
| Date Added to Maude | 2016-06-10 |
| 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 | 3 |
| Event Location | 3 |
| 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 ADHESIVE ORIGINAL CREAM, NO FLAVOR |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2016-06-10 |
| 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. Deathisabilit | 2016-06-10 |