BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN STIRRUP SYSTEM

    MDR report key: 180944 · Received August 5, 1998

    Report

    Report Number
    MW1014323
    Event Type
    Malfunction
    Date Received
    August 5, 1998
    Date of Event
    July 14, 1998
    Report Date
    July 28, 1998
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE PHYSICIAN NOTED SOME MOVEMENT OF THE PT'S LEFT LEG IN THE STIRRUP. THE NURSE CHECKED THE BOOT AND FOUND IT LOOSE. THE NURSE CONTINUED TO HOLD OR SUPPORT THE BOOT LEG DURING SURGERY. WHILE HOLDING THE BOOT IT BECAME COMPLETELY DETACHED FROM THE STIRRUP POLE AT THE WELDED SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN STIRRUP SYSTEM STIRRUP BOOT EYD ALLEN MEDICAL SYSTEMS, INC. 10020-G *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other