BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN ROLLING WALKER

    MDR report key: 2111824 · Received November 4, 2008

    Report

    Report Number
    3006459587-2008-00084
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 3, 2008
    Manufacturer
    A & E
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE EVALUATION, AS THE BOLT WORKED LOOSE FROM THE LEG, THE CONTINUED USE OF THE WALKER CAUSED THE INNER THREADS OF THE LEG TO WEAR. OVER TIME, THE THREADS WERE WORN TO THE POINT WHERE THE BOLT AND CASTER ASSEMBLY BECAME DETACHED FROM THE LEG. A FIELD ACTION SUMMARY HAS BEEN SUBMITTED TO THE FDA FOR RECOMMENDED CUSTOMER STRATEGY.

    Description of Event or Problem · 1

    PER CUSTOMER - THE FRONT RIGHT CASTER THREADS ARE STRIPPED. NO INJURY OR FALL OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN ROLLING WALKER ROLLING WALKER ITJ A & E 07889T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other