MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-05 for BOVIE PADS manufactured by Unk.
[1273198]
After removal of the bovie pads, it was noted the patient sustained 2 dime-sized burns to the left upper back. Dates of use: 2009. Diagnosis or reason for use: surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014243 |
| MDR Report Key | 1573701 |
| Date Received | 2010-01-05 |
| Date of Report | 2010-01-05 |
| Date of Event | 2009-12-01 |
| Date Added to Maude | 2010-01-13 |
| 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 | RISK MANAGER |
| 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 | BOVIE PADS |
| Generic Name | BOVIE PADS |
| Product Code | ODR |
| Date Received | 2010-01-05 |
| Lot Number | 171033 |
| ID Number | E7510-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-01-05 |