BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER SAFETYLOCK CARBON RIB-BACK BLADES

    MDR report key: 3190966 · Received June 20, 2013

    Report

    Report Number
    1836161-2013-00126
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLADE BROKE WHEN REMOVING FROM THE FOIL POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281612 BARD-PARKER SAFETYLOCK CARBON RIB-BACK BLADES BLADES SIZE 11 GES ASPEN SURGICAL PRODUCTS, INC. 371151 9315061

    Patients

    Seq Age Sex Outcome Treatment
    1