BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3981329 · Received July 24, 2014

    Report

    Report Number
    3004028675-2014-00006
    Date Received
    July 24, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDT
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    ONE DAY AFTER A CESAREAN PROCEDURE THE PT EXPERIENCED A WOUND SEPARATION WHICH WAS CLOSED WITH SUTURE AND LOCAL ANESTHESIA IN THE PT'S HOSPITAL ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435563 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDT INCISIVE SURGICAL 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention