BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASS

    MDR report key: 5649698 · Received May 12, 2016

    Report

    Report Number
    3005581270-2016-00003
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    March 15, 2016
    Report Date
    April 18, 2016
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    GXZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING HAS BEEN CORRECTED: CORRECTED TO (B)(6) 2016 FROM (B)(6) 2016. CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED 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

    THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS RE-USABLE THEREFORE NO EXPIRY DATE. 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) 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. SECTIONS STILL REQUIRE INFORMATION: AWAITING CUSTOMER RESPONSE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF BURNS TO THE SKIN AROUND ELECTRODE FOLLOWING USE OF GRASS SUBDERMAL NEEDLE ELECTRODES. CUSTOMER SAID: "PATIENT HAD A BIFRONTAL CRANIOTOMY FOR TUMOR RESECTION WITH INTRAOPERATIVE MRI IMAGING AND INTRAOPERATIVE NEUROPHYSIOLOGIC MONITORING INCLUDING SSEPS AND MERS. THE MRI WAS DONE WITH THE PLATINUM ELECTRODES IN PLACE. WHEN THE SURGICAL DRAPES WERE REMOVED BURNS WERE NOTED AT THE SITE OF THE EVOKED POTENTIAL ELECTRODES ON THE FOREHEAD AND BILATERAL CHEST. THERE WERE 2-4MM AREAS WHERE THE SKIN AROUND THE ELECTRODE APPEARED BURNED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305970 GRASS SUBDERMAL NEEDLE ELECTRODE GXZ NATUS MANUFACTURING LIMITED F-E2-48 38471

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other