BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFIN ELITE

    MDR report key: 12779442 · Received November 8, 2021

    Report

    Report Number
    MW5105176
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ALLEN STIRRUP TO LEFT LEG MALFUNCTIONED INTRA OP WHILE ADJUSTING, REPLACED AND PATIENT POSITIONED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665246 YELLOFIN ELITE SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC. SN A213333

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male