BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2512185 · Received April 2, 2012

    Report

    Report Number
    1531186-2012-00090
    Date Received
    April 2, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 30, 2012
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED WAS SITTING ON THE ROLLATOR WHEN THE WELD ON THE LEFT REAR SEAT CROSS BAR BROKE. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ HL CORP. (SHENZHEN) 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 45 MO Other