BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIBLATE 15CM

    MDR report key: 1943721 · Received December 16, 2010

    Report

    Report Number
    1056436-2010-00087
    Event Type
    Other
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE'S UNIBLATE RFA PROCEDURE FOR LIVER METASTASIS TUMOR IN (B)(6) HOSPITAL. DURING THE PROCEDURE, THE PATIENT'S SKIN WAS BURNT BY THE NEEDLE. THE DOCTOR FOUND OUT THAT IT IS BECAUSE, THE INSULATION MATERIAL OF UNIBLATE HAS FELL OFF. THE AREA OF BURNT SKIN IS 2.2CM X 1.3CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIBLATE 15CM RFA GEI ANGIODYNAMICS NA 517858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other