BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPOSE ULC 35 WIDE SKIN STAPLER

    MDR report key: 3131384 · Received May 13, 2013

    Report

    Report Number
    9610849-2013-00008
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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 PATIENT HAS DEVELOPED A NECROTIC AREA AROUND THE SITE WHERE THE STAPLE IS APPLIED. THE STAPLER WAS USED TO FIX A SPLIT THICKNESS SKIN GRAFT. NUMEROUS STAPLES HAVE BEEN APPLIED TO FIX THE GRAFT AND TO FIX THE DRESSING TO THE GRAFT SITE. THE NECROTIC AREA IS FIRST EVIDENT THREE DAYS AFTER SURGERY WHEN THE DRESSINGS ARE REMOVED FOR THE FIRST TIME. NECROTIC SITE ON LEFT LEG PATIENT FOCUSED RESOLUTION OF EVENTS AND OUTCOMES CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PATIENT: PATIENT OUTCOME: PATIENT IS STILL BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211881 APPOSE ULC 35 WIDE SKIN STAPLER DISPOSABLE SURGICAL STAPLER GDT COVIDIEN, FORMERLY NELLCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other