BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 4090007 · Received September 8, 2014

    Report

    Report Number
    3004028675-2014-00015
    Date Received
    September 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 10, 2014
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A WOUND SEPARATION A COUPLE OF DAYS AFTER A CORONARY BYPASS SURGERY. THE PATIENT WAS RE-CLOSED IN THE OPERATING ROOM WITH GENERAL ANESTHESIA AND SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550989 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDW INCISIVE SURGICAL, INC. 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention