BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 6206533 · Received May 8, 2013

    Report

    Report Number
    1000282279-2013-00014
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    May 7, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: ON 11/14/2012 - RBS - 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
    202511 MECHANICAL WALKER, ROLLATOR WALKER ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other