MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-28 for YELLOFINS STIRRUPS manufactured by Allen Medical Systems.
[1278246]
During preparation of outpatient surgical procedure, pt's legs were placed in yellofins stirrups. Pt had been given local mac and was moving about the table when the hydraulics on the left stirrup released and lowered pt's left leg with the stirrup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014125 |
| MDR Report Key | 1567405 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-12-28 |
| Date of Event | 2009-12-03 |
| Date Added to Maude | 2010-01-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFINS STIRRUPS |
| Generic Name | HYDRAULIC STIRRUPS |
| Product Code | EYD |
| Date Received | 2009-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | ONE POST OFFICE SQUARE ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-28 |