MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2009-04-07 for ALLEN MEDICAL SYSTEMS O-YFASI manufactured by Allen Medical Systems.
[1204685]
In 2009, allen medical learned of a lawsuit filed regarding a previously unreported 2008 incident involving a nurse from medical center. There was no pt involvement. According to the legal complaint, the nurse "lifted upon the stirrup to remove it from the operating table. As she lifted the stirrup out of the slot on the operating table, the stirrup unexpectedly and without warning engaged causing the stirrup to snap shut on plaintiff's left hand. " according to the document, "severe and permanent injuries" were sustained.
Patient Sequence No: 1, Text Type: D, B5
[8175674]
At the time of this report, the device has not been returned for evaluation. Co has not received photographs of the device which may help us understand the nature of the complaint. In legal documents, the serial number provided for the product was reported incorrectly. (the device is associated with a rail clamp product and not a stirrup. ) due to the lack of info, no conclusions can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221538-2009-00003 |
| MDR Report Key | 1359116 |
| Report Source | 00,07 |
| Date Received | 2009-04-07 |
| Date of Report | 2009-04-07 |
| Date of Event | 2008-05-08 |
| Date Mfgr Received | 2009-04-07 |
| Date Added to Maude | 2009-04-16 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ROYALTY, DIR |
| Manufacturer Street | ONE POST OFFICE SQUARE |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 8004335774 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN MEDICAL SYSTEMS |
| Generic Name | YELLOFIN STIRRUP |
| Product Code | EYD |
| Date Received | 2009-04-07 |
| Model Number | O-YFASI |
| Catalog Number | O-YFASI |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-04-07 |