BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER STAINLESS STEEL BLADES

    MDR report key: 3174789 · Received May 29, 2013

    Report

    Report Number
    1836161-2013-00123
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT THAT WHILE DOING A SURGICAL PROCEDURE PART NUMBER 371215/LOT 0023242 BROKE IN HALF. IT IS COMMENTED THAT IT OCCURRED 3 TIMES, EMAIL SENT TO SANDRA TO DETERMINE 3 BLADES IN ONE PROCEDURE OR 3 SEPARATE INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236391 BARD-PARKER STAINLESS STEEL BLADES BLADE # 15 GES ASPEN SURGICAL PRODUCTS, INC. 371215-150 0023242

    Patients

    Seq Age Sex Outcome Treatment
    1