MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-09 for N/A FORCE TWO E2516H manufactured by Valley Lab.
[422]
During the surgical procedure of a t & a the guaze packing in the child's mouth caught on fire from the bovie. Flames caused mouth retractor to burn and caused burns on the inside of the patient's mouth as well as portions on the outside. Flames were extinguished with large amounts of water. Child was treated with antibiotic cream. Child was kept over nightdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown, mated with incompatible equipment, other, other. Conclusion: other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 675 |
| MDR Report Key | 675 |
| Date Received | 1992-06-09 |
| Date of Report | 1992-05-27 |
| Date of Event | 1992-05-13 |
| Date Facility Aware | 1992-05-13 |
| Report Date | 1992-05-27 |
| Date Reported to FDA | 1992-05-27 |
| Date Reported to Mfgr | 1992-05-13 |
| Date Added to Maude | 1992-06-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | ELECTRO SURGICLAL UNIT ESU |
| Product Code | EKZ |
| Date Received | 1992-06-09 |
| Model Number | FORCE TWO |
| Catalog Number | E2516H |
| Lot Number | S9921/B0798 |
| ID Number | TIP- E1553 ENT/IMA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 662 |
| Manufacturer | VALLEY LAB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-06-09 |