BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD HEALTH

    MDR report key: 5754554 · Received June 24, 2016

    Report

    Report Number
    MW5063094
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    April 8, 2016
    Report Date
    May 18, 2016
    Manufacturer
    KIMBERLY CLARK
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS GENICULAR NEUROTOMY OF LEFT KNEE. DURING RADIOFREQUENCY ABLATION OF LEFT KNEE, DEVICE DID NOT HEAT UP. PT WAS UNABLE TO UNDERGO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402885 HALYARD HEALTH COOLED RADIOFREQUENCY GEI KIMBERLY CLARK TDA-PPU-1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR