BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M PRECISE VISTA DISPOSABLE SKIN STAPLER

    MDR report key: 243396 · Received October 5, 1999

    Report

    Report Number
    243396
    Event Type
    Malfunction
    Date Received
    October 5, 1999
    Date of Event
    September 27, 1999
    Report Date
    September 30, 1999
    Manufacturer
    3M HEALTHCARE
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY HAS NOTED AN INCREASE IN WOUND INFECTIONS AND INFLAMMATORY PROCESSES OF THE INCISION IN PTS HAVING UNDERGONE ORTHOPEDIC PROCEDURES, NOTEABLY IN TOTAL HIP ARTHROPLASTY, TOTAL KNEE ARTHOPLASTY, ORIF OF THE FEMUR, AND CARPAL TUNNEL PROCEDURES. THE ORTHOPEDIC SURGEON WAS QUESTIONING IF THE SKIN STAPLES WERE CAUSING THE INCREASE IN WOUND INFECTIONS AS HE NOTED THE PTS' INCISION LINES WERE BECOMING REDDENED ALMOST IMMEDIATELY. AT THE ORTHOPEDIC SURGEON'S REQUEST, THE 3M PRECISE DISPOSABLE SKIN STAPLER WAS CULTURED. THE CULTURE PLATE HAD NO GROWTH BUT THE THIO SUB TO BLOOD PLATE GREW A LIGHT GROWTH OF STAPHYLOCOCCUS EPIDERMIDIS. REPORT OF CULTURE RESULTS ARE INCLUDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M PRECISE VISTA DISPOSABLE SKIN STAPLER DISPOSABLE SKIN STAPLER GAG 3M HEALTHCARE PRODUCT #3995 FEB 95 537 95 B01

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other