BEUDAMED
    FDA Adverse Event Other Summary report: N

    RFK DISPOSABLE NEEDLE

    MDR report key: 381288 · Received March 13, 2002

    Report

    Report Number
    1222895-2002-00006
    Event Type
    Other
    Date Received
    March 13, 2002
    Date of Event
    February 25, 2002
    Report Date
    March 13, 2002
    Manufacturer
    RADIONICS
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFORMED A RADIO FREQUENCY-LESIONING IN THE MEDICAL BRANCH OF THE DORSAL ROOT RAMI ON A PATIENT AT THE L2-3 LEVEL. THE FOLLOWING DAY THE PATIENT COMPLAINED OF A BURNING SENSATION AT THE LEVEL OF THE NEEDLE ENTRY. WHEN THE DOCTOR BROUGHT THE PATIENT BACK IN, IT WAS OBVIOUS THE PATIENT HAD A SECOND DEGREE BURN PRESENT AT THE SITE OF ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFK DISPOSABLE NEEDLE ELECTRODE GXD RADIONICS RFK-C10D-S 513038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other