BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF CANNULA

    MDR report key: 7331316 · Received March 12, 2018

    Report

    Report Number
    3006630150-2018-00987
    Event Type
    Injury
    Date Received
    March 12, 2018
    Report Date
    March 12, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250010756
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: RFK-C101020S-P, LOT: UNKNOWN, DESCRIPTION: RFK CANNULA 100 MM, 10 MM TIP, 20 G, SHARP, CURVED 10/PK. MODEL: CSK-TC10, LOT: UNKNOWN, DESCRIPTION: CSK TC ELECTRODE, 10 CM. MODEL: CSK-TC15, LOT: UNKNOWN DESCRIPTION: CSK TC ELECTRODE, 15 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A FEW PATIENTS HAVE EXPERIENCED A REACTION AT THE INSERTION POINT WHERE THE CANNULA WAS INSERTED INTO THE PATIENT. THE PUNCTURE SITES WERE RAISED, HAD REDDENED, AND WERE SOMETIMES VERY ITCHY. THE PHYSICIAN DOES NOT KNOW IF THE REACTIONS ARE DEVICE RELATED. IT IS NOT KNOWN IF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172997 RF CANNULA PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL RFK-C101020S-P UNK 00813250010756

    Patients

    Seq Age Sex Outcome Treatment
    1