BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB SKIN STAPLER

    MDR report key: 5996636 · Received October 4, 2016

    Report

    Report Number
    3004028675-2016-00007
    Event Type
    Other
    Date Received
    October 4, 2016
    Report Date
    September 6, 2016
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K120373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CHEST RECONSTRUCTION SURGERY. A WOUND SEPARATION OCCURED AT SOME UNKNOWN TIME AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648509 INSORB SKIN STAPLER SKIN STAPLER GDW INCISIVE SURGICAL 2030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention