BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSMAN RADIOFREQUENCY GENERATOR

    MDR report key: 7544292 · Received May 24, 2018

    Report

    Report Number
    MW5077452
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    February 2, 2018
    Report Date
    May 5, 2018
    Manufacturer
    COSMAN MEDICAL, LLC/ BOSTON SCIENTIFIC CORPORATION
    Product Code
    GXD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING RADIOFREQUENCY DENERVATION OF THE LUMBAR AREA. PATIENT'S SKIN WAS WOUNDED (BURNED) WITH AN ELECTRODE THAT WAS NOT BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385977 COSMAN RADIOFREQUENCY GENERATOR COSMAN RADIOFREQUENCY GENERATOR GXD COSMAN MEDICAL, LLC/ BOSTON SCIENTIFIC CORPORATION G4

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention