BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA (GASROINTESTINAL ANASTOMOSI)

    MDR report key: 8522770 · Received April 16, 2019

    Report

    Report Number
    MW5085914
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC GIA 80MM X 3.8MM MISFIRED WITH ANASTOMOTIC TEAR AND LEAK 5 HOURS POST-OP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314459 GIA (GASROINTESTINAL ANASTOMOSI) STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R| S