BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF CANNULA

    MDR report key: 7336176 · Received March 13, 2018

    Report

    Report Number
    3006630150-2018-01004
    Event Type
    Injury
    Date Received
    March 13, 2018
    Report Date
    May 9, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250012040
    PMA / PMN Number
    K060799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SALES REPRESENTATIVE WAS AWARE OF THE PATIENTS ALLERGIC REACTION ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION REVEALED THAT THE RFK CANNULAS ARE COMPOSED OF 304 STAINLESS STEEL HYPO TUBING WHICH CONTAINS BOTH CHROMIUM AND NICKEL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT EXPERIENCED A REACTION THAT WAS INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN'T KNOW THE CAUSE OF THE REACTION BUT BELIEVES IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A PRESCRIPTION FOR CORTICOID AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT EXPERIENCED A REACTION THAT WAS INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN'T KNOW THE CAUSE OF THE REACTION BUT BELIEVES IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A PRESCRIPTION FOR CORTICOID AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT EXPERIENCED A REACTION THAT WAS INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN'T KNOW THE CAUSE OF THE REACTION BUT BELIEVES IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A PRESCRIPTION FOR CORTICOID AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177393 RF CANNULA PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL RFK-C101020S UNK 00813250012040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention