BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABS FIXATION DEVICE W/15 TACKS

    MDR report key: 4142938 · Received October 6, 2014

    Report

    Report Number
    1219930-2014-00918
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHEN THE THIRD TACK WAS FIRED ON COOPER'S LIGAMENT, IT HAPPENED TO SLIP. THIS CAUSED A DAMAGE ON THE ARTERY ON THE REAR SIDE OF LIGAMENT. SINCE THE BREEDING COULD NOT BE ARRESTED BY LAPARO OPERATIONS, THE PROCEDURE HAD TO BE CONVERTED INTO THE OPEN SURGERY. THE CURRENT PATIENT STATUS IS GOOD. THE TACK FELL INTO THE CAVITY SEEMED TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622537 ABS FIXATION DEVICE W/15 TACKS ABSTACK15 GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON ABSTACK15 N4F0173X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other