BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 17719116 · Received September 11, 2023

    Report

    Report Number
    3012481535-2023-00005
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    May 15, 2023
    Report Date
    September 6, 2023
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS DIAGNOSED WITH A HEMATOMA POST-OPERATION DAY 3. A DRAIN WAS PLACED. IT IS UNCLEAR HOW THE HEMATOMA WAS CAUSED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146728 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H