BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON BIOMED NEOSEALER FLO

    MDR report key: 19477062 · Received June 6, 2024

    Report

    Report Number
    3006444232-2023-00001
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 23, 2024
    Manufacturer
    NUSMILE LTD.
    Product Code
    KIF
    PMA / PMN Number
    K181917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 DURING A COMPLAINT INVESTIGATION FOLLOW-UP CALL, THE CLINICIAN WHO PERFORMED THE ROOT CANAL PROCEDURE CONFIRMED THAT THE PATIENT (MALE) HAD DEVELOPED A RASH THROUGHOUT THEIR BODY AND THAT MEDICAL INTERVENTION IN THE FORM OF A STEROID WAS PROVIDED TO HELP REMEDY THE RASH. ACCORDING TO THE CLINICIAN THE PATIENT WAS DOING FINE THE DAY FOLLOWING THE PROCEDURE ((B)(6) 2024) ASIDE FROM SINUS DRAINAGE, THE CLINICIAN PRESCRIBED MEDICATION FOR THIS SINUS DRAINAGE. THE FOLLOWING DAY ((B)(6) 2024) THE PATIENT REPORTED THAT THEY HAD A RASH ALL THROUGHOUT THEIR BODY EXCEPT FOR THEIR FACE. NO KNOWN ALLERGIES WERE REPORTED AND THE PATIENT WAS NOT ON ANY MEDICATION AT THE TIME OF THE PROCEDURE. SEVERAL INSTRUMENTS AND CHEMICALS WHERE USED IN THE TREATMENT, NEOSEALER FLO BEING ONE. WHILE THESE OTHER CHEMICALS MAY HAVE CAUSED THE RASH, NEOSEALER FLO COULD NOT BE ENTIRELY DISMISSED AS ALLERGIC RESPONSES TO MANY DENTAL MATERIALS ARE POSSIBLE. WHILE NO IMPAIRMENT TO THE FUNCTION OR PERMANENT DAMAGE OF THE BODY OCCURRED, THE MANUFACTURER (NUSMILE) HAS CHOSEN TO TAKE A PROACTIVE RESPONSE TO THIS CASE AND REPORT IN COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 0

    DOCTOR CONTACTED NUSMILE TO REPORT A PATIENT HAD DEVELOPED A RASH AFTER A ROOT CANAL PROCEDURE WAS PERFORMED. NEOSEALER FLO WAS USED AS A ROOT CANAL SEALER IN THE COURSE OF TREATMENT. NEOSEALER FLO WAS NOT CONFIRMED TO BE THE CAUSE OF THE REACTION AS MULTIPLE DENTAL PRODUCTS AND INSTRUMENTS WERE USED TO TREAT THE PATIENT IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055556 AVALON BIOMED NEOSEALER FLO MTA2.3.2 ROOT & PULP MATERIALS KIF NUSMILE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown Other