MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-12 for YELLOFIN ELITE STIRRUPS YELLOFINS * manufactured by Allen Medical Systems.
[969296]
Patient positioned properly in yellofin stirrup by nursing staff prior to starting the case. Towards the end of the case, it was noted that the yellofin malfunctioned and allowed patient's right leg to rotate externally. Patient repositioned two times. Red marks noted in areas of right knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1241946 |
| MDR Report Key | 1241946 |
| Date Received | 2008-11-12 |
| Date of Report | 2008-11-12 |
| Date of Event | 2008-09-26 |
| Report Date | 2008-11-12 |
| Date Reported to FDA | 2008-11-12 |
| Date Added to Maude | 2008-11-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFIN ELITE STIRRUPS |
| Generic Name | OR TABLE, STIRRUPS, LEG |
| Product Code | BWN |
| Date Received | 2008-11-12 |
| Model Number | YELLOFINS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1295041 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | 1 POST OFFICE SQUARE ACTON MA 01720 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-12 |