BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF CANNULA RADIOPAQUE

    MDR report key: 1961425 · Received January 14, 2011

    Report

    Report Number
    9710452-2011-00001
    Event Type
    Injury
    Date Received
    January 14, 2011
    Manufacturer
    BAYLIS MEDICAL COMPANY, INC.
    Product Code
    GXI
    PMA / PMN Number
    K972846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DHR AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED BY CUSTOMER TO KIMBERLY-CLARK FOR EVALUATION.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, " PHYSICIAN WAS PERFORMING AN RF ABLATION OF C2-C4 MEDIAL BRANCH NERVES. DURING THE PROCEDURE THE PATIENT SUPPOSEDLY SUSTAINED AN AIR EMBOLISM IN THE SPINAL CORD. THE PATIENT DISPLAYED SIGNS OF QUADRIPARESIS OR WEAKNESS IN THEIR ARMS AND LEGS. THE PATIENT HAS BEEN UNDER GOING REHAB SINCE." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF CANNULA RADIOPAQUE CANNULA GXI BAYLIS MEDICAL COMPANY, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other