BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEM'S PAL PRO STIRRUPS

    MDR report key: 449135 · Received March 19, 2003

    Report

    Report Number
    1221538-2003-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2003
    Date of Event
    February 7, 2003
    Report Date
    February 18, 2003
    Manufacturer
    THE OR GROUP
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED IN LOW LITHOTOMY. AFTER APPROXIMATELY 3 MINUTES THE BOOT PORTION OF THE RIGHT STIRRUP BROKE OFF THE MOUNT TO THE SUPPORT ROD. THE PT'S LEG WAS IMMEDIATELY PICKED UP AND PT PLACED SUPINE WITH FOAM PADDING UNDER LEGS. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM'S PAL PRO STIRRUPS LEG POSITIONING STIRRUPS FWZ THE OR GROUP NA NA

    Patients

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