BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 24211448 · Received January 29, 2026

    Report

    Report Number
    MW5183040
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    April 4, 2025
    Report Date
    January 25, 2026
    Manufacturer
    COOPERSURGICAL, INC
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FULL WOUND DEHISCENCE POD 1 S/P PRIMARY C/S AFTER USE OF INSORB STAPLER FOR CLOSURE. RESULTING IN EXTENDED HOSPITALIZATION AND BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268145 INSORB SUBCUTICULAR STAPLER STAPLE, IMPLANTABLE GDW COOPERSURGICAL, INC 2030

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Hospitalization| O