BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 2351805 · Received November 29, 2011

    Report

    Report Number
    1525712-2011-00967
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Report Date
    November 23, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL ITPR18, SERIAL NUMBER/DATE CODE IS UNKNOWN. THE USER MANUAL PART NUMBER 1143199 WAS ISSUED WITH THIS DEVICE. (B)(4). IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    CLAMPS ON BACK OF SEAT ALLEGEDLY ARE NOT HOLDING TIGHT TO THE BRACKET ON CANES OF CHAIR AND THE BACK KEEPS FALLING OFF. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTATION CUSHION 890.3175 KIC INVACARE TAYLOR STREET ITPR18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other