MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-20 for * manufactured by Aspen Surgical Products, Inc.
[19544353]
Trauma pt involved in a mva was taken to o. R. For an expanding abdominal wall hematoma. Bovie electrocautery was used to cauterize the liver laceration. The electrocautery cord was found to have a small hole in the coating which produced a very small 0. 5cm round burn on the pt's abdomen to the left of the umbilicus. The bovie machine was checked and was ok. The cord, however, was lost in transport to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 479912 |
| MDR Report Key | 479912 |
| Date Received | 2003-08-20 |
| Date of Report | 2002-12-01 |
| Date of Event | 2002-12-01 |
| Date Added to Maude | 2003-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BOVIE CORD |
| Product Code | FFZ |
| Date Received | 2003-08-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 468756 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC |
| Manufacturer Address | 7425 CLYDE PARK SW GRAND RAPIDS MI 49315 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-20 |