BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2832789 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02199
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE UNKNOWN MODEL AND SERIAL NUMBERS BARIATRIC ROLLATOR HAD A BROKEN BOLT GETTING INTO THE FRAME. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other