BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-PARKER CARBON RIB-BACK BLADES

    MDR report key: 3143079 · Received May 28, 2013

    Report

    Report Number
    1836161-2013-00122
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLADE BROKE CLEAN IN HALF ON INITIAL PUNCTURE INCISION TO THE KNEE. HALF THE BLADE REMAINED IN KNEE THEN REMOVED. MEASURED BROKEN BLADE AGAINST ANOTHER BLADE TO CONFIRM SIZE AND ALL PIECES. THEN, PROCEEDED TO TAKE AN X-RAY TO CONFIRM THAT ALL PIECES OF THE BLADE WERE REMOVED. SURGEON PROCEEDED WITH REMAINING CASES THAT DAY WITH THE SAME BLADE SIZES AND NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233518 BARD-PARKER CARBON RIB-BACK BLADES BLADES SIZE 11 GES ASPEN SURGICAL PRODUCTS, INC. 371111-150 955416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention