MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for DURA PREP 8630 manufactured by 3m.
[56506118]
Surgeon requested dura-prep during procedure for wound vac application. Dura-prep applied to the pt's abdomen. Resident requested bovie cautery device to address a small bleeder. Bovie was used and staff observed a small flame appear on the drape. The drape was lifted immediately and normal saline from the field was applied to the frame within 2 seconds. No pt r healthcare provider or staff injuries occurred. Is the product compounded? No. Is the product over-the-counter? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065203 |
| MDR Report Key | 6000155 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-09-30 |
| Date Added to Maude | 2016-10-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURA PREP |
| Generic Name | DURA PREP |
| Product Code | KOY |
| Date Received | 2016-10-04 |
| Catalog Number | 8630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Manufacturer Address | US |
| Brand Name | MEGADYNE |
| Generic Name | BOVIE CAUTERY DEVICE |
| Product Code | GEI |
| Date Received | 2016-10-04 |
| Model Number | 0035H |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE |
| Manufacturer Address | DRAPER UT 84020 US 84020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-04 |