BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547

    MDR report key: 4325522 · Received December 12, 2014

    Report

    Report Number
    1531186-2014-06194
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    October 27, 2014
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A DEALER THAT THE END USER ADVISED THAT THE WELDING AT A BAR FOR THE SEAT ON A 65650 ROLLATOR HAS BROKEN FREE FROM THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807080 ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547 WALKER, MECHANICAL ITJ HL CORP. (SHENZHEN) 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other