MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-18 for ENDO RETRACTOR 110-6888LS manufactured by Marina Medical, Inc..
[45765392]
During a surgical procedure, the pt sustained an approximate 5mm x 2 inch burn injury to the right superior chest from the adapter that is used to connect a lighted endo retractor to the light cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062405 |
| MDR Report Key | 5671056 |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-05-06 |
| Date Added to Maude | 2016-05-23 |
| 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 | ENDO RETRACTOR |
| Generic Name | ENDO RETRACTOR |
| Product Code | FDG |
| Date Received | 2016-05-18 |
| Model Number | 110-6888LS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARINA MEDICAL, INC. |
| Manufacturer Address | SUNRISE FL 33326 US 33326 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-18 |