MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-23 for LIGHT MAT SURGICAL ILLUNINATOR UA2550 manufactured by Lumitexmd.
[5487157]
During surgery, it was discovered that the patient, (b)(6) sustained a superficial skin burn on the right breast area from the lighted retractor. The patient sustained a burn to the right upper mediastinal area. The patient experienced a superficial skin burn at the mediastinal area approx. 3. 5cm long and 1 cm across. The burn was immediately treated and dressed. The light mat is a flexible illumination device that attached to a retractor and is used for breast surgery retraction. The patient was burned at the connection of the light source to the light mat. Equipment is a single patient disposable device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4593878 |
| MDR Report Key | 4593878 |
| Date Received | 2015-02-23 |
| Date of Report | 2015-02-09 |
| Date of Event | 2014-12-09 |
| Date Added to Maude | 2015-03-13 |
| 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 | 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 | LIGHT MAT SURGICAL ILLUNINATOR |
| Generic Name | LIGHT RETRACTOR |
| Product Code | FDG |
| Date Received | 2015-02-23 |
| Model Number | UA2550 |
| Catalog Number | UA2550 |
| Lot Number | 102659 |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEXMD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-23 |