MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-06 for SURGICAL INTERIM DENTURE - UPPER manufactured by California Complete Dental Laboratories.
[1807141]
Following tooth extraction, a single upper tooth surgical interim denture was provided to the pt. This denture proved unusable due to dissimilar metal chemistry and electrical-neural interaction. Dates of use: (b)(6) 2010. Diagnosis or reason for use: temporary tooth replacement. Event abated after use: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018512 |
| MDR Report Key | 1919731 |
| Date Received | 2010-12-06 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-08-11 |
| Date Added to Maude | 2010-12-16 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | SURGICAL INTERIM DENTURE - UPPER |
| Generic Name | CUSTOM MOLDED SURGICAL INTERIM DENTURE - UPPER |
| Product Code | NSK |
| Date Received | 2010-12-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CALIFORNIA COMPLETE DENTAL LABORATORIES |
| Manufacturer Address | SANTA CLARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-06 |