BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFK-C101020S

    MDR report key: 6095391 · Received November 11, 2016

    Report

    Report Number
    3004867882-2016-00002
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 27, 2016
    Report Date
    December 2, 2016
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250010756
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, WE ARE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION AS THE PRODUCT IS NOT RETURNED TO COSMAN FOR AN EVALUATION. WE ARE CONTINUING TO PURSUE THE RETURN OF THE PRODUCT FOR THOROUGH INVESTIGATION. INSPECTION OF THE IN-HOUSE INVENTORY FROM THE SAME LOT SHOW THAT PRODUCTS WERE MANUFACTURED CORRECTLY.

    Additional Manufacturer Narrative · 1

    COSMAN MEDICAL ENGINEERING TEAM PERFORMED AN EVALUATION ON EXISTING INVENTORY ON (B)(4) FROM THE LOT G301. THERE WAS NO NON-CONFORMANCE. COSMAN TEAM EVALUATED THE BOX WITH SIX REMAINING CANNULAS THAT THE FACILITY SENT FOR AN EVALUATION; SUSPECT NEEDLES WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT EXHIBITED ONE BURN ON HER BACK FOLLOWING FEW DAYS AFTER THE ABLATION. THE LOCATION WAS ON HER LOWER BACK AND THAT SHE IS A SMALLER PATIENT. THE LOCATION OF THE PATCH WAS ON HER CALF.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT EXHIBITED BURN ON HER BACK FOLLOWING FEW DAYS AFTER THE ABLATION. THE LOCATION WAS ON HER BACK. ACCORDING TO THE PHYSICIAN ASSISTANT, THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747918 RFK-C101020S RADIOFREQUECNY CANNULA GXI COSMAN MEDICAL RFK G301 00813250010756

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| O