BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD - PARKER

    MDR report key: 3101955 · Received April 22, 2013

    Report

    Report Number
    1836161-2013-00115
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RESIDENT CUTTING 1ST INNER SPACE LEFT FOOT WITH #15 BLADE. IT BROKE IN PATIENT AND BROKEN PIECE WAS RECOVERED FULLY INTACT, SURGERY CONTINUED AS DOCUMENTED. SURGEON PIECED THE BLADE TOGETHER AND THERE WERE NO VISIBLE MISSING PIECES. POST-OP X-RAY SHOWED NO FOREIGN BODY AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171769 BARD - PARKER CARBON BLADE # 15 GES ASPEN SURGICAL PRODUCTS, INC. 193475

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR