BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2602328 · Received June 7, 2012

    Report

    Report Number
    1531186-2012-00364
    Date Received
    June 7, 2012
    Report Date
    June 6, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9780, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1122173 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 IS A (B)(6) FEMALE. AND RESIDES IN A FACILITY, (B)(6). 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 CONSUMER CALLED AND STATED THAT SHE WAS UTILIZING THE 9780 SHOWER CHAIR WHEN IT ALLEGEDLY SPLIT THROUGH THE MIDDLE. THE CONSUMER MANAGED TO GRAB THE GRAB BAR TO PREVENT FROM FALLING, HOWEVER, SHE DID SUSTAIN A WRIST INJURY. THE CONSUMER WAS TO SEE A DOCTOR. THE CONSUMER HAS ALLEGEDLY BEEN USING THE PRODUCT FOR APPROXIMATELY 5 MONTHS. THE DEALER HAS CONFIRMED THAT THE SHOWER CHAIR HAS BEEN REPLACED BY THE FACILITY. THE PRODUCT IS NOT BEING RETURNED FOR AN INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED CHAIR SPLIT THROUGH THE MIDDLE. MINOR INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Other