MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-14 for DEVICE #2 UNK manufactured by Unk.
[20205201]
Pt undergoing c-section. During cauterization of superficial blood vessel, using a hemostat and bovie, the hemostat touched the skin causing a burn via conduction. The area of the skin burn was excised and the area suture. (involved equipment discarded).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 478400 |
| MDR Report Key | 478400 |
| Date Received | 2003-08-14 |
| Date of Report | 2003-08-13 |
| Date of Event | 2003-08-04 |
| Date Facility Aware | 2003-08-06 |
| Report Date | 2003-08-13 |
| Date Reported to FDA | 2003-08-13 |
| Date Added to Maude | 2003-08-20 |
| 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 | DEVICE #2 |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2003-08-14 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 467208 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-14 |