MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-07-03 for YELLOFIN ELITE STIRRUP O-YFES manufactured by Allen Medical.
[16752791]
On (b)(4) 2012, an attorney representing ob/gyn (b)(6) of (b)(6), contacted allen medical to request positioning info for our stirrups. During this contact, a previously unreported positioning injury from 2009 case was reported. According to the attorney, it was at the end of an abdominal hysterectomy case, as the pt was being removed from the operating table (dorsal / supine position), some "fresh bleeding" was noted and the surgeon asked the staff to place the still anesthetized pt into a pair of yellofin stirrups for examination. The stirrups were only used for 15 - 18 minutes and no incident occurred, the attorney said. Post-operatively in recovery, the pt reported numbness and weakness in her left leg, the attorney said. At some point later, this worsened and damage to the peroneal nerve (left side) was diagnosed.
Patient Sequence No: 1, Text Type: D, B5
[17083485]
No deficiencies or malfunctions were reported with the allen stirrup, which was not taken out of use following the 2009 procedure. The injury, which could not be attributed directly to the stirrup, was not reported to us. There has been no return of the stirrup for evaluation and the serial number - needed for identification and aging purposes, was not provided. No conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221538-2012-00003 |
| MDR Report Key | 2655746 |
| Report Source | 00 |
| Date Received | 2012-07-03 |
| Date of Report | 2012-06-05 |
| Date of Event | 2009-06-11 |
| Date Mfgr Received | 2012-06-05 |
| Date Added to Maude | 2012-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ROYALTY, DIRECTOR |
| Manufacturer Street | ONE POST OFFICE SQUARE |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 8885214277 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFIN ELITE STIRRUP |
| Generic Name | YELLOFIN ELITE |
| Product Code | BWN |
| Date Received | 2012-07-03 |
| Model Number | O-YFES |
| Catalog Number | O-YFES |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL |
| Manufacturer Address | ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-07-03 |