BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2639398 · Received July 5, 2012

    Report

    Report Number
    1531186-2012-00464
    Date Received
    July 5, 2012
    Report Date
    July 2, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9781, 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 FEMALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMERS HUSBAND CALLED STATING THAT WHEN HIS WIFE SAT ON THE 9781 SHOWER CHAIR THE SEAT ALLEGEDLY CRACKED. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES WIFE SAT ON THE CHAIR AND IT HAD CRACKED. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other