BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN MGMT RADIOFREQUENCY PRODUCTS

    MDR report key: 6487399 · Received April 12, 2017

    Report

    Report Number
    3011270181-2017-00002
    Event Type
    Injury
    Date Received
    April 12, 2017
    Report Date
    July 25, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    GXD
    PMA / PMN Number
    K072478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, 120309-001, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 14AUG2017 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 GROUND PAD IS AVAILABLE FOR EVALUATION FOR THIS COMPLAINT BUT WAS NOT RETURNED AT THE TIME THIS REPORT WAS SUBMITTED. ALL INFORMATION REASONABLY KNOWN AS OF 07APR2017 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

    PER ADDITIONAL INFORMATION RECEIVED THE CLINICIAN DID NOT CLEAN AND OR SHAVE THE AREA ON THE PATIENT WHERE THE GROUNDING PAD WILL WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE CUSTOMER HAD AN ISSUE WITH THE GROUNDING PAD RECEIVING A BURN, AND ALLEGES THE INCIDENT WAS RELATED TO A USER ERROR ON THE PAIN MANAGEMENT GENERATOR UNIT. SILVA-DINE OINTMENT WAS PRESCRIBED TO PATIENT; HOWEVER, THE DEGREE OF THE BURN WAS UNKNOWN. A TOTAL OF THREE UNITS WERE TESTED AND ONE PASSED THE TESTING. ADDITIONAL INFORMATION WAS RECEIVED ON 17-MAR-2017 THAT STATES, A NOTICE WAS RECEIVED FROM AN ENGINEER THAT TESTING CANNOT BE DONE ON-SITE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267606 PAIN MGMT RADIOFREQUENCY PRODUCTS PAIN MANAGEMENT GENERATORS & ACCESSORIES GXD HALYARD HEALTH PMG-115 120309-001

    Patients

    Seq Age Sex Outcome Treatment
    1