BEUDAMED
    FDA Adverse Event Summary report: N

    CAVILON SKIN BARRIER

    MDR report key: 2412649 · Received January 9, 2012

    Report

    Report Number
    2412649
    Date Received
    January 9, 2012
    Date of Event
    September 23, 2011
    Report Date
    January 9, 2012
    Manufacturer
    3M COMPANY
    Product Code
    KMF
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    UPON CIRCULATING IN MAIN OPERATING ROOM (OR), THE SURGEON WAS PERFORMING A DEBRIDEMENT AND VACUUM (VAC) DRESSING PLACEMENT. THE CAVILON NO STING BARRIER FILM "LOLLIPOPS" WERE HANDED ONTO THE STERILE FIELD AND USED AS A SKIN BARRIER PRIOR TO APPLICATION OF THE VAC DRESSING. SUDDENLY THE SURGEON YELLED AND AS I LOOKED UP THERE WAS A FIRE ON THE PATIENT. THE SURGEON DIRECTLY PATTED OUT THE FIRE. THE SURGICAL TECHNICIAN HANDED UP AN ASEPTO WITH SALINE TO IRRIGATE THE WOUND MULTIPLE TIMES. THE DRAPES WERE REMOVED, THROWN TO THE FLOOR AND SOAKED WITH SALINE. ONCE THE FIRE WAS EXTINGUISHED, THE PATIENT WAS ASSESSED FOR INJURIES. NO HARM OR INJURIES WERE NOTED TO PATIENT. THE SURGEON INFORMED HE USED THE ELECTROCAUTERY UNIT PRIOR TO THE SKIN BARRIER BEING DRIED WHICH CAUSED THE FIRE. OR LEADERSHIP AND SAFETY PERSONNEL ARRIVED AND DISCUSSED PERMISSION FOR CONTINUATION OF SURGICAL PROCEDURE. THE PATIENT WAS RE-PREPPED AND DRAPED. THE SURGICAL PROCEDURE CONTINUED TO COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVILON SKIN BARRIER CAVILON NO STING SKIN BARRIER LOLLIPOPS KMF 3M COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR