BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPOSE ULC 35 WIDE SKIN STAPLER

    MDR report key: 3161987 · Received May 29, 2013

    Report

    Report Number
    9610849-2013-00009
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    GDT
    PMA / PMN Number
    K900486
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT HAS DEVELOPED NECROTIC AREAS AROUND THE SITE WHERE THE STAPLES WERE APPLIED. WHEN THE NECTROTIC AREAS WERE EXCISED, TWO PIECES OF STAPLE WERE IDENTIFIED IN THE TISSUE. THESE STAPLES HAD BROKEN OFF IN THE TISSUE. THE NECROTIC SITE WAS EXCISED AND THE WOUND IS HEALING. NO OTHER MEASURES TAKEN. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THE PT IS STILL BEING MONITORED. AS WITH THE OTHER MDR IN THIS UNIT THERE IS NO LOT NUMBER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234035 APPOSE ULC 35 WIDE SKIN STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDT COVIDIEN, FORMERLY NELLCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR