BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOFREQUENCY GENERATOR

    MDR report key: 5615684 · Received April 28, 2016

    Report

    Report Number
    2183870-2016-00334
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K141858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN TREATED TWO VEINS USING ABLATION THERAPY WITH AN RFG3 GENERATOR. TEN TO 14 DAYS POST PROCEDURE IT WAS REPORTED THAT THE VEINS RE-OPENED. THE PATIENT HAD FOLLOWED POST PROCEDURE INSTRUCTIONS, INCLUDING WEARING COMPRESSION SOCKS. THIS SAME GENERATOR HAS BEEN USED SUCCESSFULLY IN MANY OTHER TREATMENTS. RE-TREATMENT IS PLANNED FOR THE PATIENT. NO OTHER CLINICAL COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270873 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention