BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 4231684 · Received October 13, 2014

    Report

    Report Number
    1836161-2014-00059
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EMAIL STATED, "THIS BLADE CAME OUT OF A CUSTOM KNEE PACK THROUGH MEDICAL ACTION. WHEN THE CUSTOMER OPENED IT, IT WAS MISSING THE TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645926 BARD-PARKER #11 BLADE GES ASPEN SURGICAL PRODUCTS, INC. 0051803

    Patients

    Seq Age Sex Outcome Treatment
    1