BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2132712 · Received June 10, 2011

    Report

    Report Number
    2132712
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALLEN A HILL-ROM COMPANY
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    AFTER DRAPES WERE REMOVED FROM PT IN OR, RNFA FOUND RIGHT LEG ACUTELY BENT AND OUT OF THE BOOT OF THE STIRRUP. THE BOOT WAS TOO LOOSE, WHICH ALLOWED THE LEG TO MIGRATE OUT. RIGHT LEG FOUND ACUTELY BENT AND OUT OF THE STIRRUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PNEUMATIC STIRRUP FWZ ALLEN A HILL-ROM COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *