BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2641553 · Received July 6, 2012

    Report

    Report Number
    1531186-2012-00481
    Date Received
    July 6, 2012
    Report Date
    July 5, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 6358, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1020707 REV H (JAN-09) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER CALLED STATING THAT THE SEAT ON THE 6358 SHOWER COMMODE CHAIR ALLEGEDLY BROKE AT THE HINGES. THE DEALER ALSO ALLEGES THAT THE FABRIC ON THE BACK OF THE SEAT SHREDDED AND HAD TORN AWAY FROM THE METAL. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THAT THE SEAT FABRIC ON THE BACK SHREDDED AND TORE AWAY FROM THE METAL AND THE SEAT BROKE AT THE HINGES AFTER SIX MONTHS. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 6358

    Patients

    Seq Age Sex Outcome Treatment
    1 Other