BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB ABSORBABLE STAPLES

    MDR report key: 8857059 · Received July 31, 2019

    Report

    Report Number
    MW5088696
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    June 29, 2019
    Report Date
    July 25, 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 (EXPLORATORY LAPAROTOMY) AND ON POT -OP DAY 3 THE INCISION DEHISCED. THIS REQUIRED ADD'L MEDICAL INTERVENTIONS. WE ARE NOT POSITIVE OF THE LOT NUMBER AS IT OCCURRED 48-72 HOURS LATER AND PACKAGING NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638803 INSORB ABSORBABLE STAPLES STAPLE, IMPLANTABLE GDW INCISIVE SURGICAL, INC. 2030 191501

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R