BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 4264365 · Received October 30, 2014

    Report

    Report Number
    3004028675-2014-00019
    Date Received
    October 30, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 2, 2014
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A WOUND SEPARATION AFTER A CESAREAN SECTION PROCEDURE. THE PATIENT WAS RE-CLOSED IN THE PATIENT'S HOSPITAL ROOM WITH METAL STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696028 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GAG INCISIVE SURGICAL, INC. 2030 142301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention