BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASS ELECTRODES

    MDR report key: 6126503 · Received November 23, 2016

    Report

    Report Number
    3005581270-2016-00010
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 21, 2016
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXY
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR WAS OBTAINED AND REVIEWED. ALL MANUFACTURING WORK STEPS HAVE BEEN COMPLETED AND SIGNED FOR AS PER ROUTE CARD. IN PROCESS TEST FORM FOR GRASS ELECTRODES WAS REVIEWED. ALL TESTS WERE COMPLETED AND SIGNED OFF. NO FAILURES RECORDED. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A LETTER LISTING OUTSTANDING INFORMATION HAS BEEN SENT TO CUSTOMER TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO SUBMIT FOLLOW UP REPORT AND/OR EXPLAIN WHY REQUIRED INFORMATION WAS NOT PROVIDED AND STEPS TAKEN TO OBTAIN SUCH INFORMATION.

    Additional Manufacturer Narrative · 1

    NO ISSUES WITH THE PRODUCTION OF THIS LOT OF ELECTRODES. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT HAS BEEN REPORTED THAT THE DEVICE CAUSED WOUNDS/BLISTERS. BASED UPON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN WHETHER PATIENT FACTORS OR CLEANING/DISINFECTING PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. QUESTIONNAIRES SENT TO THE CUSTOMER TO GET MORE INFORMATION IN RELATION TO HOW ELECTRODES WERE CLEANED AND STERILISED PRIOR TO USE. CUSTOMER HAS BEEN CONTACTED ON THREE OCCASIONS WITH A LETTER LISTING REMAINING REQUIRED INFORMATION BELOW IN ORDER TO SUBMIT THE FOLLOW UP REPORT. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT AND PRODUCT DETAILS. (B)(4). CORRECTIONS: INITIAL REPORTER SHOULD REFERENCE THE HEALTHCARE FACILITY THAT REPORTED THE ADVERSE EVENT TO THE MANUFACTURER. (B)(4) WOULD LIKE TO CORRECT THIS SECTION FROM THE INITIAL REPORT 3005581270-2016-00010 TO THE FOLLOWING: (B)(6). DEVICE MANUFACTURE DATE (MM/DD/YYYY) - INFORMATION IN THE INITIAL REPORT ''HIS SECTION IS NOT APPLICABLE AS MANUFACTURER DO NOT SPECIFY THE DEVICE MANUFACTURE DATE'' HAS BEEN PROVIDED INCORRECTLY. (B)(4) WOULD LIKE TO CORRECT THIS SECTION FROM THE INITIAL REPORT 3005581270-2016-00010 TO THE FOLLOWING: DEVICE MANUFACTURE DATE IS 02/22/2016.

    Description of Event or Problem · 1

    RECENTLY CUSTOMER NOTED THAT WHERE THE ELECTRODES ARE, WHEN TAKING THEM OFF, THERE ARE WOUNDS! (SOUNDS LIKE BLISTERS FROM CHEMICAL REACTION). ALSO THE INSIDE OF THE ELECTRODES DISCOLOR, WITHOUT THE COATING BEING DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774594 GRASS ELECTRODES GRASS GENUINE CUP ELECTRODES GXY NATUS MANUFACTURING LIMITED FS-E5GH-60 48514

    Patients

    Seq Age Sex Outcome Treatment
    1 Other