BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 2111866 · Received November 4, 2008

    Report

    Report Number
    3006459587-2008-00080
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    August 14, 2008
    Report Date
    November 3, 2008
    Manufacturer
    A&E
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE ROOT CAUSE OF FAILURE. PRODUCT BROKE AT THE WELD JOINT.

    Description of Event or Problem · 1

    END USER WAS WALKING WITH WALKER WHEN THE BACK LEG BROKE. THE LEG BROKE AT THE WELD JOINT AND THE USER FELL. SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN ROLLING WALKER ITJ A&E 07887B

    Patients

    Seq Age Sex Outcome Treatment
    1