MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-10 for LIGHTMAP REF SA3550 manufactured by Lumitex Md.
[52210394]
Upon undraping the patient, we discovered that the patient had a burn at the area where the light mat and deaver had been placed upon her. When we looked at the light mat that had been used, we saw that the plastic at the area where the light mat connects to the cord was melted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064051 |
| MDR Report Key | 5875129 |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-10 |
| Date of Event | 2016-07-25 |
| Date Added to Maude | 2016-08-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHTMAP |
| Generic Name | SURGICAL ILLUMINATOR |
| Product Code | FDG |
| Date Received | 2016-08-10 |
| Model Number | NA |
| Catalog Number | REF SA3550 |
| Lot Number | 103337 |
| ID Number | PN#005539 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX MD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-10 |