BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC TACKER

    MDR report key: 96246 · Received June 5, 1997

    Report

    Report Number
    MW1011410
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    November 1, 1996
    Report Date
    June 5, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A HERNIA REPAIR PROCEDURE, TACKS WERE BEING USED TO ATTACH THE MESH TO THE TISSUE. ABOUT 6 WEEKS AFTER SURGERY, PT COMPLAINED OF PAIN. THE PAIN RESOLVED ONCE THE TACKS WERE REMOVED. DR BELIEVES THE TACKS ARE TOO LARGE AND GO IN TOO DEEP INTO THE TISSUE. THIS PROBLEM HAS OCCURRED 12 TIMES IN THE PAST 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC TACKER TISSUE FASTENER GDO ORIGIN MEDSYSTEMS, INC. UNK 0403972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention TROCAR