BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS PAL STIRRUP

    MDR report key: 597043 · Received October 27, 2005

    Report

    Report Number
    1221538-2005-00002
    Event Type
    Injury
    Date Received
    October 27, 2005
    Date of Event
    May 12, 2003
    Report Date
    April 1, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT THEY WAS INJURED DUE TO BEING POSITIONED IN THE STIRRUP FOR AN EXTENDED PERIOD OF TIME WHICH ALLEGEDLY CAUSED A BREAKDOWN OF THE MUSCLE TISSUE IN THEIR CALVES AND RELEASED A SUBSTANCE THAT WAS DAMAGING TO THEIR KIDNEYS. THERE WAS NO ALLEGATION OF MALFUNCTION WITH THE DEVICE. THE MANUFACTURER BECAME AWARE OF THIS INCIDENT WHEN THE LEGAL DEPARTMENT OF THE PARENT CORPORATION REQUESTED COMPLAINT INFORMATION ON THIS USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS PAL STIRRUP LEG POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS A-10023-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention