BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4945078 · Received September 4, 2013

    Report

    Report Number
    1000282279-2013-00161
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    September 4, 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

    Additional Manufacturer Narrative · 1

    THERE IS NO WAY OF KNOWING WHETHER THIS DEVICE WAS MANUFACTURED BY FOSHAN R. POON MEDICAL PRODUCTS CO., LTD SINCE THERE WAS NO MODEL NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: 03/28/2013 - RBS - IT WAS REPORTED BY THE CONSUMER THAT THE UNSPECIFIED WALKER LOCK PUSH BUTTON WAS BROKEN. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440094 MECHANICAL WALKER, ROLLATOR WALKER ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other