BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3232200 · Received December 5, 2012

    Report

    Report Number
    1000282279-2012-00035
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE 66500 BARIATRIC ROLLATOR RIGHT BRAKE BECAME LOOSE, AND ATTEMPTS TO TIGHTEN IT HAVE FAILED CAUSING IT NOT TO ENGAGE THE BRAKE TO WHEEL, AND TWO SPOKES WERE BROKEN TOWARD THE TOP OF THE RIGHT WHEEL, WHICH WAS DAMAGED. THERE WAS NO INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR WALKER ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. 66500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other