MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for ILED-7 manufactured by Trumpf Medical Systems.
[95733852]
Patient undergoing open heart surgery, noted that exposed skin appeared very red under lights after close of 4-5 hour case. Drapes removed, redness resolved several hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074185 |
| MDR Report Key | 7142143 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-12-15 |
| Date Added to Maude | 2017-12-22 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILED-7 |
| Generic Name | LIGHT, SURGICAL |
| Product Code | FSQ |
| Date Received | 2017-12-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDICAL SYSTEMS |
| Manufacturer Address | CHARLESTON NC 29492 US 29492 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-21 |