BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESIGNER QUAD CANE

    MDR report key: 8292749 · Received January 31, 2019

    Report

    Report Number
    1056127-2019-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 31, 2019
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    UDI-DI
    00754756913052
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PER DEALER, END USER WAS USING CANE NORMALLY WHEN SHAFT BROKE AND END USER FELL. NO INJURIES WERE REPORTED. DEALER REFUSED TO GIVE INFORMATION ON END USER. DATA FOR EU IS APPROXIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86461 DESIGNER QUAD CANE QUAD CANE IPS HOMECARE ENTERPRISE CO. LTD. C-604S-CD04 N/A 00754756913052

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR