BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN S.A.M. STIRRUP/TABLE CLAMP

    MDR report key: 264508 · Received February 18, 2000

    Report

    Report Number
    MW1018218
    Event Type
    Malfunction
    Date Received
    February 18, 2000
    Date of Event
    February 14, 2000
    Report Date
    February 15, 2000
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ALLEN STIRRUPS FELL DURING A VAGINAL PROCEDURE CAUSING THE PTS LEG TO FALL. "ANKLE WAS TWISTED" UPON INSPECTING ALLEN STIRRUPS NOTED THAT THE PORTION THAT GOES INTO THE HOLDER WAS WORN SMOOTH CAUSING THE STIRRUPS TO BE UNSTABLE. HOLDERS WERE SUPPLIED BY MFR OF THE ALLEN STIRRUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN S.A.M. STIRRUP/TABLE CLAMP * EYD ALLEN MEDICAL SYSTEMS ALLEN S.A.M. STIRRUP *
    2 TABLE CLAMP TABLE CLAMP BWN ALLEN MEDICAL SYSTEMS 40017 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR