BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLIEF* MULTI-COOLED RADIOFREQUENCY KIT

    MDR report key: 7069383 · Received November 29, 2017

    Report

    Report Number
    8030647-2017-00136
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    October 18, 2017
    Report Date
    January 10, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    GXI
    UDI-DI
    10680651405903
    PMA / PMN Number
    K053082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M7045D210, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. NO ROOT CAUSE WAS IDENTIFIED AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 29NOV2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT STATES, THE PAIN MANAGEMENT DIRECTOR REPORTED THAT THE PATIENT HAD BEEN DISCHARGED ONE WEEK AFTER HOSPITALIZATION, AND SENT HOME ON IV ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INFECTION POST PROCEDURE WHERE COOLIEF PROBES WERE UTILIZED. AN INFECTION WAS NOTED ON (B)(6) 2017. THE PATIENT HAD A L4/L5 COOLED RF PROCEDURE AND ADMITTED TO HOSPITAL ON (B)(6) 2017 WITH ABSCESS NOTED AT THE SITE. BLOOD CULTURES WERE POSITIVE FOR STAPH INFECTION. THE PATIENT IS BEING TREATED WITH IV ANTIBIOTICS, REMAINS HOSPITALIZED. ADDITIONAL INFORMATION WAS RECEIVED ON 14-NOV-2017 THAT STATES, THE PROCEDURE WAS A RIGHT RADIOFREQUENCY ABLATION OF L2, L3, L4, L5. ONE KIT WAS USED AND THE "ABSCESS" WAS IDENTIFIED AT L4-L5. THERE WAS NO IMMEDIATE TISSUE REACTION AND STEROIDS WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847650 COOLIEF* MULTI-COOLED RADIOFREQUENCY KIT COOLED RF PROBES AND CANNULAS GXI HALYARD HEALTH MCK3-17-100-4 M7045D210 10680651405903

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other