BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANES

    MDR report key: 2041940 · Received March 29, 2011

    Report

    Report Number
    1525712-2011-00143
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    UNK
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE GETTING OF BED, PATIENT REPORTEDLY PUT HIS WEIGHT ON THE CANE. INVACARE CANES ARE DESIGNED TO PROVIDE SUPPORT, INCREASED STABILITY AND ASSISTANCE TO AN INDIVIDUAL WHILE WALKING. IT IS NOT INTENDED TO SUPPORT THE FULL WEIGHT OF THE USER. CURRENT USER GUIDES COVER THIS STABILITY ISSUE. MANUFACTURER IS WORKING TO OBTAIN THE PRODUCT FOR AN EVALUATION. MALFUNCTION IS NOT CONFIRMED. MDR FILED AS A CONSUMER ALLEGEDLY WENT TO THE HOSPITAL.

    Description of Event or Problem · 1

    THE CONSUMER WAS GETTING OUT OF BED AND PUT HIS WEIGHT ON THE CANE WHEN THE CANE ALLEGEDLY COLLAPSED, CAUSING THE CONSUMER TO FALL AND HIT HIS HEAD ON THE DRESSER. ALTHOUGH THE CONSUMER ALLEGEDLY WENT TO THE HOSPITAL, THE EXTENT OF THE ALLEGED INJURY IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANES 890.3075 IPS UNK 8917 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention