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 |