BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASS GENUINE CUP ELECTRODES

    MDR report key: 6629165 · Received June 9, 2017

    Report

    Report Number
    3005581270-2017-00006
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 12, 2017
    Report Date
    May 15, 2017
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXY
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS BEEN ASKED PRELIMINARY ANALYSIS QUESTIONS TO UNDERSTAND THE SEQUENCE OF THE SLEEPING STUDY AND DIFFERENT EQUIPMENT USED THAT LEAD TO THE REPORTED ADVERSE EVENT. CUSTOMER CONFIRMED THAT PATIENT DID NOT HAVE AND MRI AND NO DEFIBRILLATOR WAS USED. ELECTRODES CONNECTED TO THE PATIENT WERE OF THE SAME TYPE. CUSTOMER ADVISED THAT THERE IS NO PERMANENT DAMAGE EXPECTED AND THERE WAS NO HOSPITALIZATION LENGTHENED DUE TO THE BURNS. PATIENT IS HEALING WELL. FURTHER INVESTIGATION IS REQUIRED TO DETERMINE POSSIBLE ROOT CAUSE. CUSTOMER HAS BEEN CONTACTED VIA EMAIL WITH QUESTIONNAIRE TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW. PATIENT IDENTIFIER - AWAITING CUSTOMER RESPONSE. AGE AT THE TIME OF EVENT, DATE OF BIRTH - AWAITING CUSTOMER RESPONSE. SEX - AWAITING CUSTOMER RESPONSE. WEIGHT - AWAITING CUSTOMER RESPONSE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - AWAITING CUSTOMER RESPONSE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.) - AWAITING CUSTOMER RESPONSE. LOT # - AWAITING CUSTOMER RESPONSE CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - AWAITING CUSTOMER RESPONSE. HEALTH PROFESSIONAL? - AWAITING CUSTOMER RESPONSE. OCCUPATION - AWAITING CUSTOMER RESPONSE. DEVICE MANUFACTURE DATE (MM/DD/YYYY) - AWAITING CUSTOMER RESPONSE TO PROVIDE LOT#. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE SERIAL #. EXPIRATION DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE DEVICE IS REUSABLE. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERM(S) - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED, CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I(F), LIST CORRECTION/REMOVAL REPORTING NUMBER. - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER HAS NOT BEEN PROVIDED AS CUSTOMER CONSIDERS IT CONFIDENTIAL.

    Description of Event or Problem · 1

    PATIENT WITH BURN SPOT. SECOND DEGREE BURN WAS DISCOVERED ON PATIENT'S HEAD AND EAR AFTER 22 HOUR STUDY. THERE WAS YELLOW PUS IN THE CAP AFTER ELECTRODE REMOVAL. LOCATIONS OF THE BURNS COINCIDE WITH THE LOCATIONS OF THE ELECTRODES. IT WASN'T THE FIRST USE OF THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411964 GRASS GENUINE CUP ELECTRODES RECORDING ELECTRODES GXY NATUS MANUFACTURING LIMITED F-E6GH-48

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other