BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFK CANNULA

    MDR report key: 7403060 · Received April 6, 2018

    Report

    Report Number
    3006630150-2018-01266
    Event Type
    Injury
    Date Received
    April 6, 2018
    Report Date
    April 6, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250012040
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6). 2018. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL: RFK-C101020VZ-P, LOT #: L359, DESCRIPTION: SILICONIZED, (VZ) RF CANNULA,10 CM,10 MM,20 G, 10/PK. THE DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT DEVELOPED TEMPORARY WEALS AT THE CANNULA INSERTION SITES A WEEK AFTER THE PROCEDURE. THE PATIENT'S SKIN WAS ITCHY. THE PHYSICIAN SAYS IT APPEARS TO BE TYPE 4 (DELAYED SKIN IMMUNE CELL MEDIATED) HYPERSENSITIVITY RESPONSE. IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS PERFORMED. THE PHYSICIAN PREPPED THE PATIENT'S SKIN WITH CHLORAPREP. THE PHYSICIAN IS UNSURE, BUT BELIEVES IT IS POSSIBLE THAT CHLORAPREP COULD BE THE CAUSE OR THE CAUSE COULD BE THE CANNULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245012 RFK CANNULA PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL RFK-C101020SZ-P J256 00813250012040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention