MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-26 for LIGHTMAT UA2550 manufactured by Lumitex.
[17137123]
Pt in the operating room for bilateral mastectomy and reconstruction. The lightmat, surgical illuminator, was used through out the procedure. During the procedure, the light cord same in contact with pt causing 3 different burns. The lightmat as uses with the recommended light cord from lumitex and a stryker x8000 light source at 100%. It was noted that the metal connection piece between the lightmat and the light cord became very hot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030716 |
| MDR Report Key | 3202300 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-06-14 |
| Date Added to Maude | 2013-07-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTMAT |
| Generic Name | SURGICAL ILLUMINATOR |
| Product Code | HJM |
| Date Received | 2013-06-26 |
| Model Number | UA2550 |
| Catalog Number | UA2550 |
| Lot Number | I02386 |
| Device Expiration Date | 2016-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-26 |