BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR

    MDR report key: 4355515 · Received November 3, 2014

    Report

    Report Number
    3005419473-2014-00001
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MASS CORP
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS USING ROLLATOR (ROLLING WALKER) WHEN WHERE BROKE RESULTING IN CUSTOMER, FALLING AND BREAKING ANKLE. CUSTOMER WAS USING AS A TRANSPORT CHAIN AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703027 ROLLATOR TRANSPORT CHAIR AND ROLLATOR IN ONE ITJ MASS CORP HE2160011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention