BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATOR 9153651315

    MDR report key: 4395369 · Received January 8, 2015

    Report

    Report Number
    9615290-2015-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ORIGINAL ORDER # (B)(4) SERIAL NUMBER (B)(4) TBM STEVE ADVISED THAT THE ROLLATOR HAS HAD MULTIPLE DEFECTIVE BRAKES. HOLD FOR NICK ONG TO REWORK BRAKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19638 ROLLATOR 9153651315 WALKER, MECHANICAL ITJ DOLOMITE AB JAZZLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other