MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-02 for PERFECTEMP BATTERY OPERATED CAUTERY * 0231 manufactured by Aaron Medical Industries.
[173031]
Intraoperative flash fire during ectropion repair of eyelid resulting in 2nd degree facial burn. Pt expired on 5/4/00.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 280421 |
| MDR Report Key | 280421 |
| Date Received | 2000-06-02 |
| Date of Report | 2000-06-02 |
| Date of Event | 2000-04-19 |
| Date Facility Aware | 2000-04-19 |
| Report Date | 2000-06-02 |
| Date Reported to FDA | 2000-06-02 |
| Date Reported to Mfgr | 2000-06-02 |
| Date Added to Maude | 2000-06-06 |
| 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 |
| 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 | PERFECTEMP BATTERY OPERATED CAUTERY |
| Generic Name | BATTERY OPERATED CAUTERY |
| Product Code | HQP |
| Date Received | 2000-06-02 |
| Model Number | * |
| Catalog Number | 0231 |
| Lot Number | 1299C |
| ID Number | * |
| Device Expiration Date | 2003-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 271382 |
| Manufacturer | AARON MEDICAL INDUSTRIES |
| Manufacturer Address | 1640 CENTRAL AVE ST. PETERSBURG FL 33712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4 | 1. Hospitalization; 2. Required No Informationntervention | 2000-06-02 |