MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-31 for LUMITEXMD LIGHT MAT UA2550 -LIGHT MAT- manufactured by Lumitex.
[1418319]
Patient underwent cystocele repair with mesh. When drapes were taken off of the patient, a quarter sized second-degree skin burn was noted at the 4:00 position, the patient's left abdomen, lateral to the umbilicus. Surgeon injected 10ml of 0. 25 bupivacaine, applied silvadene and covered it with a tegaderm. Plastic surgeon later contacted for a consult and wound management. Thought to have been from the male/female attachments. Product instructions in the core indicate that acmi light cord can be used with the lumitex light mat - the item that burned the patient-. However, according to the vp of sales with lumitex, they only recommend using their specially designed light cords which have a heat deflecting element in the portion of the light cord which burned the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014230 |
| MDR Report Key | 1571434 |
| Date Received | 2009-12-31 |
| Date of Report | 2009-12-31 |
| Date of Event | 2009-12-22 |
| Date Added to Maude | 2010-01-11 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMITEXMD LIGHT MAT |
| Generic Name | LIGHT MAT |
| Product Code | HJN |
| Date Received | 2009-12-31 |
| Catalog Number | UA2550 -LIGHT MAT- |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | P.O. BOX 74853 CLEVELAND OH 44190 US 44190 |
| Brand Name | ACMI CORD |
| Generic Name | CORD |
| Product Code | HJN |
| Date Received | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | P.O. BOX 74853 CLEVELAND OH 44190 US 44190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-31 |