BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 HOLE FOOTPIECE SET IN 5 IN WHEEL

    MDR report key: 2171877 · Received March 10, 2007

    Report

    Report Number
    3006112083-2007-00005
    Event Type
    Malfunction
    Date Received
    March 10, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 23, 2007
    Manufacturer
    A & E INDUSTRIES
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE WHEELS WERE VOLUNTARILY RECALLED IN (B)(6) 2006. THIS IS AN ONGOING AND ACTIVE SEARCH FOR PURCHASERS OF THIS PRODUCT.

    Description of Event or Problem · 1

    CONTACT STATES THE END-USER FELL AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 HOLE FOOTPIECE SET IN 5 IN WHEEL WHEEL ITJ A & E INDUSTRIES 07722-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other