BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAL PRO STIRRUP

    MDR report key: 2858016 · Received November 2, 2012

    Report

    Report Number
    2858016
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S LEG WAS IN STIRRUPS WHEN ONE OF THE STIRRUPS FAILED ALLOWING THE LEG TO FALL.MANUFACTURER RESPONSE FOR STIRRUP, PALPRO STIRRUP (PER SITE REPORTER).MFG HAS BEEN VERY COOPERATIVE AND RESPONSIVE TO OUR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAL PRO STIRRUP ACCESSORIES, OPERATING-ROOM, TABLE FWZ ALLEN MEDICAL SYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR