MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-16 for ELECTROCAUTERY F95 manufactured by Valley Lab.
[27461846]
During tonsillectomy flames ignited in (b)(6) female mouth. Flames immediately extinguished. Burns inside mouth were not extensive but included inner left check, left side of tongue, and tip of tongue, and one spot on the uvula. Case was completed and pt transferred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5124745 |
| MDR Report Key | 5124745 |
| Date Received | 2004-03-16 |
| Date of Report | 2004-03-16 |
| Date of Event | 2004-03-05 |
| Report Date | 2004-03-16 |
| Date Reported to FDA | 2004-03-16 |
| Date Reported to Mfgr | 2004-03-16 |
| Date Added to Maude | 2015-10-02 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECTROCAUTERY |
| Generic Name | NONE |
| Product Code | HAM |
| Date Received | 2004-03-16 |
| Model Number | F95 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALLEY LAB |
| Manufacturer Address | 5920 LONG BOW DRIVE BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-16 |