BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 583049 · Received March 4, 2005

    Report

    Report Number
    3004028675-2005-00002
    Event Type
    Other
    Date Received
    March 4, 2005
    Date of Event
    January 25, 2005
    Report Date
    February 22, 2005
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MEDLINE INCISION FOR A TAH/BSO PROCEDURE WAS CLOSED IN 2005 WITH SUBCUTICULAR STAPLES AND AUGMENTED WITH SUPPORTING SUTURE FOR DEEP WOUND SUPPORT. ON THE FIRST POST-OPERATIVE DAY, PORTIONS OF THE SKIN INCISION SEPARATED, ALTHOUGH THE DEEP WOUND SUPPORT WAS NEVER COMPROMISED. PATIENT WAS TREATED IN A BRIEF INTERVENTION BY CLOSING WITH METAL SKIN STAPLES UNDER A LOCAL ANESTHESIA. THE PATIENT WAS DISCHARGED ONE DAY EARLY. NO ADDITIONALY COMPLICATIONS WERE COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SKIN STAPLER GDW INCISIVE SURGICAL, INC. INSORB 20 044401

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other