BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE SEAT CANE

    MDR report key: 5538976 · Received March 31, 2016

    Report

    Report Number
    1056127-2016-00003
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    UDI-DI
    00754756140144
    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

    END USER FELT SEAT TIPPING ON THIS SEAT CANE. WHEN SHE STOOD UP SHE SAW THAT THE LEG HAD CRACKED AND FALLEN OFF. SHE DID NOT FALL OR SUFFER ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192933 ENDURANCE SEAT CANE SEAT CANE IPS HOMECARE ENTERPRISE CO. LTD. 6054 00754756140144

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR