MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-03 for DURAPREP 8630 manufactured by 3m Healthcare.
[777432]
Fire in o. R.. Pt involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004868 |
| MDR Report Key | 975302 |
| Date Received | 2008-01-03 |
| Date of Report | 2007-01-03 |
| Date of Event | 2007-01-02 |
| Date Added to Maude | 2008-01-09 |
| 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 |
| 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 | DURAPREP |
| Generic Name | SURGICAL PREP |
| Product Code | KOY |
| Date Received | 2008-01-03 |
| Catalog Number | 8630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 943518 |
| Manufacturer | 3M HEALTHCARE |
| Brand Name | VALLEYLAB |
| Generic Name | BOVIE |
| Product Code | GEI |
| Date Received | 2008-01-03 |
| Model Number | ELECTROSURGERY BROKEN PENCIL |
| Catalog Number | E2515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 943519 |
| Manufacturer | US SURGICAL/VALLEYLAB |
| Manufacturer Address | 150 GLOVER AVE NOWALK CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2008-01-03 |