BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM SUBDERMAL NEEDLE ELECTRODE

    MDR report key: 3836043 · Received May 2, 2014

    Report

    Report Number
    3005581270-2014-00003
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 31, 2014
    Manufacturer
    GRASS TECHNOLOGIES
    Product Code
    IKT
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EVALUATED BY MANUFACTURER AS DEVICE WASN'T RETURNED. 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. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - AWAITING CUSTOMER RESPONSE. LOT # - AWAITING CUSTOMER RESPONSE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - AWAITING CUSTOMER RESPONSE. DEVICE MANUFACTURE DATE (MM/DD/YYYY) - AWAITING CUSTOMER RESPONSE (LOT# TO IDENTIFY THE DEVICE MANUFACTURE DATE). USAGE OF DEVICE - AWAITING CUSTOMER RESPONSE.

    Description of Event or Problem · 1

    WHEN DRAPES REMOVED AFTER 18 DEGREE PROCEDURE SMALL RED SPOT NEAR SIDE OF MOUTH AND SMALL SPOT NEAR CENTER OF UPPER CHEST. PT HAD SUBDERMAL LEADS IN PLACE ON THAT AREA OF THE FACE. RN IS UNCERTAIN IF PATIENT HAD LEAD ON CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264018 PLATINUM SUBDERMAL NEEDLE ELECTRODE SUBDERMAL ELECTRODES, 882.1350 IKT GRASS TECHNOLOGIES F-E2-48

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other