BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIFTSET TOPICAL SKIN ADHESIVE

    MDR report key: 4903485 · Received July 9, 2015

    Report

    Report Number
    1219930-2015-00523
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    June 19, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    MPN
    PMA / PMN Number
    K122446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PEDIATRIC SURGERY. ACCORDING TO THE REPORTER: THE SURGEON CALLED TO REPORT A DEHISCENCE OF A FOREHEAD LACERATION DUE TO THE USE OF THE PRODUCT. A CHILD CAME TO THE EMERGENCY ROOM (ER) WITH AN APPROXIMATE 1 CENTIMETER LACERATION TO THE FOREHEAD. THE WOUND WAS CLEANED AND THE PRODUCT WAS APPLIED WITH THE APPLICATOR TIP. THE WOUND EDGES WERE APPROXIMATED, PRODUCT APPLIED TWICE, AND WOUND EDGES HELD TOGETHER FOR APPROXIMATELY 2 MINUTES. A BANDAGE WAS PLACED OVER THE WOUND AND INSTRUCTIONS WERE SENT HOME FOR WOUND CARE. THE CHILD RETURNED TO THE ER THE NEXT DAY WITH DEHISCENCE. THE ER DOCTOR WHO SAW THE PATIENT REPORTED THE PRODUCT APPEARED "FLAKY" AND EASILY REMOVABLE. ANOTHER PRODUCT WAS APPLIED TO THE WOUND AND THE PATIENT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447002 SWIFTSET TOPICAL SKIN ADHESIVE SKIN ADHESIVE MPN COVIDIEN, FORMERLY US SURGICAL A DIVISON SS6

    Patients

    Seq Age Sex Outcome Treatment
    1