MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-11 for SUNOPTIC HEADLIGHT CORD/CABLE WO45220 UNKNOWN manufactured by Sunoptic Technologies.
[1013155]
During the case md stated "felt something hot on my back". Rn immediately unplugged head light from power, examined cord and found rubber sheath around light cord fibers torn with a burn area identified. No smoke, no flames, removed cord from room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1312927 |
| MDR Report Key | 1312927 |
| Date Received | 2009-02-11 |
| Date of Report | 2009-02-11 |
| Date of Event | 2009-01-20 |
| Report Date | 2009-02-11 |
| Date Reported to FDA | 2009-02-11 |
| Date Added to Maude | 2009-02-18 |
| 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 | SUNOPTIC HEADLIGHT CORD/CABLE |
| Generic Name | HEADLIGHT, SURGICAL, CABLE |
| Product Code | FSR |
| Date Received | 2009-02-11 |
| Model Number | WO45220 |
| Catalog Number | UNKNOWN |
| Lot Number | REUSEABLE CABLE/NOT STERILE |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNOPTIC TECHNOLOGIES |
| Manufacturer Address | 6018 BOWENDALE AVE. JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-11 |