BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONVERTOR DRAPE (2 DRAPES USED)

    MDR report key: 267002 · Received March 1, 2000

    Report

    Report Number
    267002
    Event Type
    Other
    Date Received
    March 1, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 11, 2000
    Manufacturer
    CONVERTORS
    Product Code
    KDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR THROMBECTOMY WITH POSSIBLE REVISION OF GORTEX GRAFT OF LEFT FOREARM. WHILE IN THE OPERATING ROOM, A VALLEYLAB CAUTERY PENCIL WAS USED ON SURGICAL INCISION. THE SURGEON NOTICED SMOKING OF SURGICAL DRAPE AND SUBSEQUENT FLAME OF DRAPE. FLAME IMMEDIATELY EXTINGUISHED. PT SUSTAINED SECOND DEGREE BURN IN THE OPERATING RECORD - THIS RECORDED AS 2CM X 2CM ON LEFT AXILLARY REGION. A TOP DRAPE AND SPLIT DRAPE WERE USED. UNSURE AS TO WHETHER PACK WAS USED FOR CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERTOR DRAPE (2 DRAPES USED) STERILE SURGICAL DRAPE KDD CONVERTORS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other VALLEYLAB CAUTERY PENCIL MODEL# E2515HNSB. OXYGEN| THERAPY VIA MASK IN USE AT TIME OF EVENT.