BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE SEAT CANE

    MDR report key: 5787687 · Received July 12, 2016

    Report

    Report Number
    1056127-2016-00006
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    July 3, 2019
    Report Date
    July 3, 2019
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    UDI-DI
    00754756140144
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 0

    THIS SEAT CANE WITH A BROKEN LEG IS A RECURRANCE OF A FAILURE LAST SEEN IN 2016. THE DEALER DID NOT HAVE ANY ACCURATE INFORMATION ABOUT THE USER OR THE CIRCUMSTANCES UNDER WHICH THE BREAK OCCURRED. THIS REPORT IS BEING FILED AS THE FIRST FOLLOW-UP TO THE ORIGINAL 2016 COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER WAS TRYING OUT THIS SEAT CANE IN A HOME MEDICAL STORE WHEN A LEG BROKE. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440079 ENDURANCE SEAT CANE SEAT CANE IPS HOMECARE ENTERPRISE CO. LTD. 6054 N/A 00754756140144

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR