BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2140569 · Received June 16, 2011

    Report

    Report Number
    1525712-2011-00264
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    KENSTONE METAL
    Product Code
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLIANCE ADMINISTRATOR ALLEGES THE CONSUMER FELL FACE FIRST, WAS BRUISED BUT HAD "NO SIGNIFICANT INJURIES." ALLEGEDLY, THE BRACKETS BROKE ON THE KNEE WALKER. MAINTENANCE HISTORY IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE BRACKETS ALLEGEDLY BROKE AND THE CONSUMER FELL FACE FIRST ON THE FLOOR. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE N/A KENSTONE METAL 65960

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR