BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFRI MEDICAL SYNFLO CS 540

    MDR report key: 681554 · Received February 10, 2006

    Report

    Report Number
    MW1038012
    Event Type
    Injury
    Date Received
    February 10, 2006
    Date of Event
    October 1, 2005
    Report Date
    February 10, 2006
    Manufacturer
    AFRI MEDICAL CO
    Product Code
    LLB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFRI MEDICAL CO. WHICH IS CLEARED IN THE US MARKET BY ESTABLISHMENT REGISTRATION HAS BEEN INVESTIGATED BY THE LOCAL COMPETENT AUTHORITY, AND THE INVESTIGATION REVEALS A LOT OF BREACHING AND VIOLATION WHICH IS FOLLOWED BY MANDATORY STOP OF THE PRODUCTION LINE. THE LOCAL COMPETENT AUTHORITY HAS BEEN CONTACTED TO CONFIRM THE ACTION TAKEN, AND THE INJUNCTION ACTION HAS BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFRI MEDICAL SYNFLO CS 540 SYNFLOW LLB AFRI MEDICAL CO ALL MODELS ALL LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening