MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-26 for BATTERY OPERATE CAUTERY 0011055401 * manufactured by Medichoic.
[364733]
Battery operated cautery used. Ignited sponge during surgery and burned upper lip, right lower lip, roof of mouth, and tongue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 528417 |
| MDR Report Key | 528417 |
| Date Received | 2004-02-26 |
| Date of Report | 2004-01-13 |
| Date of Event | 2004-01-02 |
| Report Date | 2004-01-13 |
| Date Reported to FDA | 2004-01-13 |
| Date Reported to Mfgr | 2004-01-13 |
| Date Added to Maude | 2004-06-08 |
| 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 | 3 |
| 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 | BATTERY OPERATE CAUTERY |
| Generic Name | * |
| Product Code | HQP |
| Date Received | 2004-02-26 |
| Model Number | 0011055401 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2006-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 517606 |
| Manufacturer | MEDICHOIC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-26 |