MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-19 for LIGHTMAT * manufactured by Lumitex, Inc..
[1395182]
Noted burn on left upper arm of patient during breast surgery-three 10 mm blisters. It is thought to be due to the connection between the end of the disposable lightmat and the gray non-disposable light cord which is attached to the xenon light box. This connection became very hot. Apparently the connection between the disposable lighted retractor and the nondisposable cord gets really hot. ====================== health professional's impression======================apparently the connection between the disposable lighted retractor and the nondisposable cord gets really hot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1709655 |
| MDR Report Key | 1709655 |
| Date Received | 2010-05-19 |
| Date of Report | 2010-05-19 |
| Date of Event | 2010-05-18 |
| Report Date | 2010-05-19 |
| Date Reported to FDA | 2010-05-19 |
| Date Added to Maude | 2010-06-03 |
| 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 | LIGHTMAT |
| Generic Name | SURGICAL ILLUMINATOR |
| Product Code | HJN |
| Date Received | 2010-05-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | L01369 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX, INC. |
| Manufacturer Address | 8443 DOW CIR. STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-19 |