BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE MONOPOLAR NEEDLE 37MM X 28GA

    MDR report key: 4917831 · Received July 14, 2015

    Report

    Report Number
    3005581270-2015-00001
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 15, 2015
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K973442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE SERIAL # IF IMPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. ALSO, IS THIS A SINGLE USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PT IN THE INITIAL REPORT HAS ''NO'', NAME AND ADDRESS OF REPROCESSOR THEN APPLICABLE ONLY IF ''YES'' 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 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. THE FOLLOWING STILL REQUIRE INFORMATION: PATIENT IDENTIFIER - AWAITING CUSTOMER RESPONSE. AGE AT 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AT DESIGN, BIOCOMPATIBILITY TESTING WAS CONDUCTED AND PASSED SENSITIVITY TESTS PER THE ISO 10993 STANDARD. THERE HAVE BEEN NO STERILIZATION, MATERIAL, PROCESS OR CHEMICAL CHANGES WHEN MFG/PROCESSING THE MONOPOLAR NEEDLE ELECTRODES. THE RETAINS FOR THIS LOT WERE INSPECTED FOR WEAK SEAL PATTERNS, OPEN POUCHES, HOLES IN THE FILM AND VOIDS IN THE SEAL, NO DEFECTS WERE OBSERVED. CERTIFICATE OF IRRADIATION FROM STERILIZATION FACILITY WAS REVIEWED. STERILIZATION PARAMETERS ARE CORRECT AND DOSE APPLIED TO THIS LOT IS WITHIN SPEC AND PRODUCT HAS BEEN STERILIZED CORRECTLY. NO QUALITY ISSUES ASSOCIATED WITH THIS LOT. NO REWORK/ SORTS APPLICABLE. A REVIEW OF THE COMPLAINTS LOG SHOWS NO OTHER COMPLAINTS RAISED FOR THIS LOT. PACKAGING IN PROCESS TESTS RESULTS WERE REVIEWED. VISUAL CHECKS ON POUCH SHOW THAT ALL PASSED. SEAL STRENGTH TEST RESULTS WERE REVIEWED. ALL RESULTS WERE WITHIN SPEC.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT DEVELOPED AN INFECTION IN THEIR FOREARM THREE (3) DAYS AFTER TREATMENT USING A MONOPOLAR NEEDLE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457558 DISPOSABLE MONOPOLAR NEEDLE 37MM X 28GA ELECTRODE IKT NATUS MANUFACTURING LIMITED 902-DMF37-TP U1503G09

    Patients

    Seq Age Sex Outcome Treatment
    1 Other