BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB ABSORBABLE STAPLES

    MDR report key: 8826409 · Received July 24, 2019

    Report

    Report Number
    MW5088362
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 19, 2019
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABSORBABLE STAPLES USED TO CLOSE ABDOMINAL INCISION (C-SECTION) AND ON POST-OP DAY ONE. INCISION WAS FOUND OPEN 80%. THIS REQUIRED RE-STAPLING OF INCISION WITH METAL STAPLES. WE ARE NOT POSITIVE OF THE LOT NUMBER, AS ISSUE OCCURRED 24 HOURS LATER AND SO PACKAGING NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618614 INSORB ABSORBABLE STAPLES STAPLE, IMPLANTABLE GDW INCISIVE SURGICAL, INC. 2030 192001

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R