MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-01 for HAND HELD CAUTERY PENCIL N/A 288-4424 manufactured by Conmed.
[2732]
Other devices in use: bard power plus 5000no text sent with reportdevice labeled for single use. Patient medical status prior to event: unknown. There was multiple patient involvement. Number of patients involved: 2. 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, electrical tests performed, performance tests performed. Results of evaluation: design, electrical problem - open circuit, telemetry failure, mated with incompatible equipment. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4513 |
| MDR Report Key | 4513 |
| Date Received | 1993-02-01 |
| Date of Report | 1992-12-31 |
| Date of Event | 1992-07-14 |
| Date Facility Aware | 1992-07-14 |
| Report Date | 1992-12-31 |
| Date Reported to Mfgr | 1992-07-14 |
| Date Added to Maude | 1993-05-26 |
| 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 | HAND HELD CAUTERY PENCIL |
| Product Code | HIM |
| Date Received | 1993-02-01 |
| Model Number | N/A |
| Catalog Number | 288-4424 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4232 |
| Manufacturer | CONMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-01 |