BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE SEAT CANE

    MDR report key: 6159248 · Received December 9, 2016

    Report

    Report Number
    1056127-2016-00015
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 9, 2016
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    UDI-DI
    00754756914509
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S SPOUSE TOOK THIS SEAT CANE OUT OF CAR TRUNK AND NOTICED THAT THE LEG WAS BROKEN AT THE CROSS BOLT. THERE WAS NO FAILURE REPORTED DURING USE AND THERE WAS NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809482 ENDURANCE SEAT CANE SEAT CANE IPS HOMECARE ENTERPRISE CO. LTD. 6053 N/A 00754756914509

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR