MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-20 for LIGHTMAT SURGICAL ILLUMINATOR UA2550 manufactured by Lumitexmd, Inc..
[2983665]
A pt sustained a second degree burn (1 cm x 0. 5 cm) on her left chest from the lightmat surgical illuminator connector. The light source was used during right axillary sentinel node removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027939 |
| MDR Report Key | 2858093 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-11-16 |
| Date of Event | 2012-11-14 |
| Date Added to Maude | 2012-12-06 |
| 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 |
| 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 SURGICAL ILLUMINATOR |
| Generic Name | SURGICAL ILLUMINATOR |
| Product Code | HJN |
| Date Received | 2012-11-20 |
| Model Number | NA |
| Catalog Number | UA2550 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEXMD, INC. |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-20 |