BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2604027 · Received June 8, 2012

    Report

    Report Number
    1531186-2012-00362
    Date Received
    June 8, 2012
    Report Date
    June 4, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED AS PART OF CAPA (B)(4) DID NOT REVIEW ALL NO MDR QUERY RESULTS. THIS COMPLAINT WILL BE FILED ON AS A RESULT OF THE RETROSPECTIVE REVIEW. NO RMA HAD BEEN INITIATED FOR THIS ISSUE. MODEL 9780, SERIAL NUMBER/DATE CODE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1122173 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL COULD ALSO BE FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAD FULLY READ AND UNDERSTOOD THE OWNER'S MANUAL. DOCUMENTATION PROVIDED WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DID NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD HAVE CONTACT INVACARE. THE CONSUMER IS A FEMALE WHO WEIGHS (B)(6). HER AGE AND HEIGHT 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.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED WHILE USING CHAIR, IT COLLAPSED UNDERNEATH HER. 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 Other