MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-30 for OVAL BURR 2093-236 2096-236 manufactured by Conmed Linvatec.
[5499095]
Bur broke during use x2 from the same lot. Devices returned to vendor/manufacturer along with handpiece. No pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040592 |
| MDR Report Key | 4491565 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-30 |
| Date of Event | 2014-12-15 |
| Date Added to Maude | 2015-02-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OVAL BURR |
| Generic Name | BURR |
| Product Code | HBG |
| Date Received | 2015-01-30 |
| Returned To Mfg | 2014-12-22 |
| Model Number | 2093-236 |
| Catalog Number | 2096-236 |
| Lot Number | 533357 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO 33773 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-30 |