MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-04 for SUPER POLIGRIP manufactured by Glaxosmithkline.
[15011072]
Disability or permanent damage. Dose: 1. Denture cream. 2. Sea bond. Frequency: 1 x daily. 3 x week. Route: oral. Oral. Dates of use: 2000 - 2009. 2006. Diagnosis or reason for use: denture adhesive cream. Denture adhesive wafers. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011349 |
| MDR Report Key | 1399516 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-02-01 |
| Date Added to Maude | 2009-06-16 |
| 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 | NONE |
| Product Code | KOL |
| Date Received | 2009-06-04 |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Brand Name | SEA BOND DENTURE ADHESIVE WAFERS |
| Generic Name | NONE |
| Product Code | KOP |
| Date Received | 2009-06-04 |
| Lot Number | R08G083 |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-06-04 |