BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 596872 · Received April 27, 2005

    Report

    Report Number
    3004028675-2005-00006
    Event Type
    Other
    Date Received
    April 27, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 27, 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

    MIDLINE INCISION CLOSURE OF A MYOMECTOMY WAS PERFORMED. PARTIAL WOUND SEPARATION OCCURRED 36 HOURS POST-OPERATIVELY. REPAIRED BY APPROXIMATION UNDER LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SKIN STAPLER GDW INCISIVE SURGICAL, INC. INSORB 20 050401

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R