BEUDAMED
    FDA Adverse Event Other Summary report: N

    YELLOFIN STIRRUPS

    MDR report key: 438539 · Received January 2, 2003

    Report

    Report Number
    1221538-2003-00001
    Event Type
    Other
    Date Received
    January 2, 2003
    Date of Event
    January 1, 2001
    Report Date
    October 1, 2001
    Manufacturer
    THE OR GROUP
    Product Code
    FWZ
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A TRACTION INJURY OF THE NERVES WHICH INNERVATE THEIR LOWER LEG. THIS OCCURRED WHILE THE PATIENT WAS UNDERGONING SURGERY IN THE LITHOTOMY POSITION. THE O.R. MANAGER REPORTED THAT THE PROBLEM WAS MOST LIKELY CAUSED BY A USER POSITIONING ERROR OR A PATIENT ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOFIN STIRRUPS LEG POSITIONING STIRRUPS FWZ THE OR GROUP N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other ANESTHESIA USED DURING SURGERY| OPERATING TABLE USED DURING SURGERY