BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOFREQUENCY CANNULA

    MDR report key: 6095405 · Received November 11, 2016

    Report

    Report Number
    3004867882-2016-00003
    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
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    COSMAN ENGINEERING TEAM EVALUATED THE REMAINING INVENTORY OF RFK-C101020 S FROM THE SAME LOT G301 AND THERE WAS NO NON-CONFORMANCE FOUND. ADDITIONALLY, THE FACILITY SENT THE REMAINING SIX CANNULAS IN UNOPENED POUCH FROM THE SAME BOX ON NOV 14TH, BUT THE SUSPECT NEEDLES WERE NOT SENT, AND THERE WAS NO NON-CONFORMANCE FOUND ON THE REMAINING NEEDLES. RELATED MEDICAL DEVICE WAS EVALUATED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME WE ARE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ON THE CAUSE OF THE BURN DUE TO THE PRODUCT NOT BEING RETURNED TO (B)(6) MEDICAL. WE ARE CONTINUING TO PURSUE THE RETURN OF THE PRODUCT FOR COMPLAINT EVALUATION. PHOTO WAS SENT TO (B)(6) AND IT SHOWS RED SPOTS BUT NOT BURNS. LOOKS LIKE RESULT OF NEEDLE PUNTURE OR ALLERGIC REACTION. INSPECTION OF PRODUCT IN-HOUSE SHOWS THAT ALL UNITS IN LOT WERE MANUFACTURED CORRECTLY. DEVICE NOT RETURNED TO COMPANY.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT EXHIBITED 3 BURNS ON HER BACK. SHE FEELS ITCHY AND HAS THE RED SPOTS AT THE LOCATION. SHE IS CURRENTLY DOING OK BUT WILL KEEP DOCUMENTATION OF HERSELF.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT HAS THREE BURNS. SHE CURRENTLY FEELS ITCHY, AND HAS THE RED SPOTS IN THE AREA. THE LOCATION WAS ON HER LOWER BACK AND THE PATCH WAS ON HER CALF AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748564 RADIOFREQUENCY CANNULA RF CANNULA GXI COSMAN MEDICAL RFK-C101020S G301 00813250010756

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O