MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for INTEGRA LUXTEC ROLLING LIGHT SOURCE manufactured by Integra York Pa, Inc..
[61442450]
Patient Sequence No: 1, Text Type: N, H10
[61442451]
Lux rolling light source began to smoke and smell of electric smoke so it was immediately unplugged and equipment moved away from patient and sequestered. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6144863 |
| MDR Report Key | 6144863 |
| Date Received | 2016-12-05 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-11-16 |
| Report Date | 2016-11-18 |
| Date Reported to FDA | 2016-11-18 |
| Date Reported to Mfgr | 2016-11-18 |
| Date Added to Maude | 2016-12-05 |
| 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 | 3 |
| Brand Name | INTEGRA LUXTEC ROLLING LIGHT SOURCE |
| Generic Name | SOURCE, CARRIER, FIBEROPTIC LIGHT |
| Product Code | EQH |
| Date Received | 2016-12-05 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-05 |