MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-13 for CAVILON NO STING BARRIER FILM - 3M manufactured by .
[989078]
When using electrosurgical pencil to cauterize bleeding around surgical wound, vapors from cavilon barrier film pad ignited, causing cavilon pad to catch fire and burn. Diagnosis or reason for use: cleaning skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008965 |
| MDR Report Key | 1230090 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-06 |
| Date of Event | 2008-11-05 |
| Date Added to Maude | 2008-11-17 |
| 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 | 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 | CAVILON NO STING BARRIER FILM - 3M |
| Generic Name | NONE |
| Product Code | KOY |
| Date Received | 2008-11-13 |
| Lot Number | 38-9019-0529-9 |
| Device Expiration Date | 2011-06-01 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1281461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-13 |