MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-16 for LUMITEX MD LIGHTMAT SURGICAL ILLUMINATOR UA 2550 manufactured by Lumitex Md, Inc.
[5656891]
A lightmat surgical illuminator by lumitex md (ref#ua2550, lot 102659) was being used during a bilateral mastectomy procedure. The illuminator was connected to a gyrus acmi g93 4 mm fiber optic light cable which was connected to an integra luxtec 300 mlx xenon light source. The surgeon noted during the first part of the procedure that the illuminator light was dim. It was then noted that the skin over the sternum had been burned. The metal connection between the light cable and the illuminator appeared to have come in contact with the skin in the area of the sternum. The burn covered an estimated 4 x 3 cm area that appeared to be mostly superficial and partial thickness. An estimated 2 x 1 cm portions of the burn injury appeared to be a full thickness burn. There were also a couple of very small, punctate areas of burn on the left upper chest wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041509 |
| MDR Report Key | 4616989 |
| Date Received | 2015-03-16 |
| Date of Report | 2015-03-05 |
| Date of Event | 2014-02-11 |
| Date Added to Maude | 2015-03-19 |
| 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 | LUMITEX MD LIGHTMAT SURGICAL ILLUMINATOR |
| Generic Name | LIGHTMAT SURGICAL ILLUMINATOR |
| Product Code | HJM |
| Date Received | 2015-03-16 |
| Catalog Number | UA 2550 |
| Lot Number | 102659 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX MD, INC |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-16 |