BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIONICS

    MDR report key: 149484 · Received February 5, 1998

    Report

    Report Number
    MW1013008
    Event Type
    Malfunction
    Date Received
    February 5, 1998
    Date of Event
    January 28, 1998
    Report Date
    February 4, 1998
    Manufacturer
    RADIONICS
    Product Code
    JXO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RADIO FREQUENCY ELECTRODE TIP RETAINED BELOW THE SUBCUTANEOUS TISSUE OF LEFT SIDE OF FACE OF PT IN OR. NO PLANS TO RETRIEVE TIP OF ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIONICS ELECTRODE JXO RADIONICS RFG-3B *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other