BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HURRISEAL DENTIN DESENSITIZER

    MDR report key: 7426942 · Received April 12, 2018

    Report

    Report Number
    0001413399-2018-00001
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    BEUTLICH PHARMACEUTICALS, LLC
    Product Code
    KLE
    PMA / PMN Number
    K973002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING PENDING ANALYTICAL RESULTS OF THE RETURNED MEDICAL DEVICE. BEUTLICH IS NOT AWARE OF ANY ADDITIONAL TREATMENTS/DEVICES/DRUGS APPLIED CONCURRENTLY TO THE PATIENT, NOR ARE WE AWARE OF ANY PATIENT CONDITIONS OR RISK FACTORS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE CONDITIONS EXPERIENCED BY THE PATIENT. AS INFORMATION IS GATHERED AT THE CONCLUSION OF THE INVESTIGATION AND ANALYTICAL TESTING, BEUTLICH WILL SUBMIT A SUPPLEMENTAL REPORT. IT IS ANTICIPATED TO HAVE ALL DATA ACQUIRED ON OR BEFORE MARCH 31, 2018. COMPLETE ANALYSIS OF THE RETURNED DEVICE REVEALED NO CHARACTERISTIC OUT OF SPECIFICATION RANGE. NO FAILURE OF THE MEDICAL DEVICE COULD BE DETERMINED. NO DETERMINATION CAN BE MADE REGARDING THE PROPER DEVICE USAGE ACCORDING TO THE IFU, HOWEVER THE REPORTER DESCRIBED A HISTORY OF CORRECT PRACTICE WITH THE DEVICE. IT IS THE CONCLUSION OF THIS INVESTIGATION THAT THERE MAY HAVE BEEN SOME LEVEL OF SENSITIVITY ON THE PART OF THE PATIENT TO ONE OR MORE INGREDIENTS WITHIN THE DEVICE FORMULA. THIS IS A KNOWN AND DOCUMENTED RISK WITH THIS DEVICE AND HAS BEEN REDUCED AS FAR AS POSSIBLE, BUT NOT ELIMINATED.

    Description of Event or Problem · 1

    ON FRIDAY (B)(6) 2018 BEUTLICH REGULATORY AFFAIRS WAS CONTACTED BY DR. (B)(6) STATING THAT A PATIENT HAD REPORTED BEING TREATED FOR PAIN, BLISTERS, SWELLING, AND THRUSH IN THE ORAL CAVITY FOLLOWING A PROCEDURE INVOLVING HURRISEAL DENTIN DESENSITIZER. ACCORDING TO THE DENTIST, THE PATIENT, (B)(6) YEAR OLD FEMALE, WAS TREATED ON (B)(6) 2018 WITH HURRISEAL LOT Y048EP ACCORDING TO THE ENCLOSED IFU (ISOLATED WITH COTTON, APPLICATION WITH MICRO BRUSH, ALLOWED TO DRY, REPEAT.) FOR RELIEF OF THE PATIENT HYPERSENSITIVITY TO COLD. FOLLOWING THIS APPLICATION, THE PATIENT REPORTED BACK TO THE DENTIST OFFICE (B)(6) THAT SHE REQUIRED MEDICAL TREATMENT AT A LOCAL HOSPITAL FOR: BLISTERS TO THE INSIDE OF BOTH CHEEKS, SWELLING OF THE TONGUE, AND A RASH. THE PATIENT REPORTED THAT THE HOSPITAL DETERMINED SHE HAD ORAL CANDIDIASIS "THRUSH" AND SHE RECEIVED CARE FROM THE HOSPITAL IN THE FORM OF AN ANTIHISTAMINE, APPLICATION OF AN ORAL PASTE, AND AN ORAL RINSE. SHE WAS THEN DISCHARGED. ANY FURTHER ATTEMPTS FROM HILLTOP DENTISTRY TO CONTACT THE PATIENT FOR UPDATED INFORMATION WERE UNSUCCESSFUL AND, TO DATE, HAVE BEEN UNANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267126 HURRISEAL DENTIN DESENSITIZER AGENT, TOOTH BONDING, RESIN - DESENSITIZER KLE BEUTLICH PHARMACEUTICALS, LLC 12ML Y048EP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R