BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEM'S PAL PRO STIRRUP

    MDR report key: 449782 · Received March 20, 2003

    Report

    Report Number
    1221538-2003-00004
    Event Type
    Malfunction
    Date Received
    March 20, 2003
    Date of Event
    February 21, 2003
    Report Date
    February 21, 2003
    Manufacturer
    THE OR GROUP
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE STIRRUP AND THE NURSE WAS TIGHTENING THE HANDLE TO LOCK THE BOOT IN PLACE AND THE STIRRUP BOOT BROKE OFF ITS MOUNT.

    Devices

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

    Patients

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