MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for AUTO BRITE ILLUMINATOR II MODEL ABI-II 3180 manufactured by Dyonics.
[265]
Light source was found on patient's thigh. Burn size 3/4 cm round. Third degree scar. Consult to plastic surgery. Recommendation for surgical repairdevice not 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 not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, incorrect technique/procedure. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 947 |
| MDR Report Key | 947 |
| Date Received | 1992-07-21 |
| Date of Report | 1992-06-01 |
| Date of Event | 1992-05-15 |
| Date Facility Aware | 1992-05-18 |
| Report Date | 1992-06-01 |
| Date Reported to FDA | 1992-06-01 |
| Date Added to Maude | 1992-07-29 |
| 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 | AUTO BRITE ILLUMINATOR II |
| Generic Name | N/A |
| Product Code | FTG |
| Date Received | 1992-07-21 |
| Model Number | MODEL ABI-II |
| Catalog Number | 3180 |
| Lot Number | N/A |
| ID Number | SNHZ 0191 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 903 |
| Manufacturer | DYONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-21 |