BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE SEAT CANE

    MDR report key: 5847470 · Received August 4, 2016

    Report

    Report Number
    1056127-2016-00008
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 28, 2016
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    UDI-DI
    00754756914509
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THIS SEAT CANE WHICH IS 5 YEARS OLD HAS BEEN IN THE HOME CARE STORE AND BROKE DURING A DEMONSTRATION. STAFF IS UNSURE IF CUSTOMER WAS UNFOLDING IT OR SITTING ON IT WHEN SEAT BRACKET BROKE. THERE WAS NO INJURY AND NO PERSONAL DETAILS OF THE CUSTOMER WERE TAKEN. AGE AND WEIGHTS ARE ONLY ESTIMATES OF AVERAGE USERS WHO HAVE MAY HAVE TRIED THE UNIT WHILE IT WAS ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499147 ENDURANCE SEAT CANE SEAT CANE IPS HOMECARE ENTERPRISE CO. LTD. 6053 N/A 00754756914509

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR