BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COOLED RF PROBES AND CANNULAS

    MDR report key: 6106388 · Received November 16, 2016

    Report

    Report Number
    3011270181-2016-00017
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    September 8, 2016
    Report Date
    April 2, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    GXI
    PMA / PMN Number
    PUNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION - DATE OF EVENT IS (B)(6) 2016 NOT (B)(6) 2016. ALL INFORMATION REASONABLY KNOWN AS OF 04APR2017 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT UNDERWENT A COOLED RF PROCEDURE OF EITHER THE LUMBAR OR SACRAL SPINE ON A UNITED STATES AIR FORCE BASE IN THE (B)(6), ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT REPORTEDLY PASSED AWAY FROM AN INFECTION OF FLESH EATING BACTERIA. THE PHYSICIAN WAS UNABLE TO PROVIDE INFORMATION IF THE DEVICE USED WAS SINGLE USE PER PATIENT OR PER PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759017 UNKNOWN COOLED RF PROBES AND CANNULAS COOLED PROBE ASSEMBLY GXI HALYARD HEALTH 9843418 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death