BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133278 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00908
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    November 20, 2012
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013. BROKEN SEAT ON COMMODE, PER DEALER. NO SERIAL NUMBER GIVEN, HOWEVER THE PART NUMBER, 1112182, IS ASSOCIATED WITH ONLY THREE MODELS OF COMMODES ALL MANUFACTURED AT INVAMEX. THEY ARE THE 9630-4, 9630-1, AND 9650-4. MDR FILED.

    Description of Event or Problem · 1

    THE DEALER ADVISED A REPLACEMENT SEAT WAS SENT OUT ON A NO CHARGE WARRANTY ORDER (B)(4). THE ASSOCIATE IS NO LONGER EMPLOYED AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235497 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other