BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2316144 · Received October 31, 2011

    Report

    Report Number
    1525712-2011-00708
    Date Received
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA 859595929 HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9781 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 MONTHS OLD. THE USER MANUAL PART NUMBER 1122173 REV C (JAN-09) WAS ISSUED WITH THIS DEVICE. 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 IS A FEMALE WITH AN UNKNOWN AGE AND HEIGHT. SHE WEIGHS (B)(6). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF ADDITIONAL LOADING TO THE DEVICE. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE SEAT OF THE SHOWER CHAIR ALLEGEDLY SPLIT IN HALF FROM SIDE TO SIDE. INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other