BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3232199 · Received December 5, 2012

    Report

    Report Number
    1000282279-2012-00036
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE USER WAS PROPELLING HIMSELF BACKWARDS, AND THE BOLT HOLDING THE LEFT FRONT WHEEL TO THE ROLLATOR SHEARED OFF. THE OWNER'S MANUAL CAUTIONS ON PAGE 1 INCLUDE: ROLLATORS ARE NOT INTENDED TO BE PROPELLED WHILE SEATED. IT WAS LEARNED THAT THE END USER WAS SEATED BACKWARDS AND WAS PROPELLING. NO INJURY. (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 35 YR Other