MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-27 for SUPER POLIGRIP SUPER STRONG ALL manufactured by Glaxosmithkline.
[17472874]
Numbness and tingling with balance problems and the loss of sensation and unexplained pain and issues walking, the primary physician thought i had a stroke and sent me to neurologist. Denture realigned every 2 years by dr yeaton as insurance would allow. Dose or amount: upper and lower, frequency: as needed, route: dental. Dates of use: (b)(6) 2010. Diagnosis or reason for use: to hold dentures on the advice of dentist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018733 |
| MDR Report Key | 1943965 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-27 |
| Date of Event | 2010-03-05 |
| Date Added to Maude | 2011-01-11 |
| 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 | 3 |
| 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 | SUPER POLIGRIP |
| Generic Name | DENTURE CREAM |
| Product Code | KOP |
| Date Received | 2010-12-27 |
| Model Number | SUPER STRONG ALL |
| Catalog Number | POLIGRIP |
| Device Expiration Date | 2010-07-04 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-27 |