MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-30 for POLIGRIP manufactured by Glaxosmithkline.
[18489954]
I used fixodent and poligrip from (b) (6) 2007 until (b) (6) 2010. I began experiencing numbness and tingling in my extremities. I received my blood work results on (b) (6) 2010 and found out my zinc level was 218, copper was normal at 96. My doctor wants to follow up with blood test and neuropathy treatment. Dose or amount: denture cream, frequency: once daily, route: oral. Dates of use: (b) (6) 2007 - (b) (6) 2010. Diagnosis or reason for use: denture adhesive cream. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015353 |
| MDR Report Key | 1649717 |
| Date Received | 2010-03-30 |
| Date of Report | 2010-03-22 |
| Date of Event | 2010-01-15 |
| Date Added to Maude | 2010-04-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP |
| Generic Name | NONE |
| Product Code | KOQ |
| Date Received | 2010-03-30 |
| Lot Number | UNK |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Brand Name | FIXODENT |
| Generic Name | NONE |
| Product Code | KOL |
| Date Received | 2010-03-30 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2010-03-30 |