MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-10 for QUIK-FIX manufactured by Pertussin Laboratories Div. Brimms.
[8080]
Development of mucoepidermoid carcinoma hard palate directly beneath home-repair of maxillary denture several months previously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000066 |
| MDR Report Key | 10452 |
| Date Received | 1993-12-10 |
| Date of Report | 1993-10-19 |
| Date of Event | 1993-09-08 |
| Date Added to Maude | 1993-12-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUIK-FIX |
| Generic Name | HOME DENTURE REPAIR KIT |
| Product Code | EBO |
| Date Received | 1993-12-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10452 |
| Manufacturer | PERTUSSIN LABORATORIES DIV. BRIMMS |
| Manufacturer Address | TONAWANDA NY 14150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Not Applicable; 2. Hospitalization; 3. Life Threatening | 1993-12-10 |