BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HURRISEAL DENTIN DESENSITIZER

    MDR report key: 20035946 · Received August 22, 2024

    Report

    Report Number
    0001413399-2024-00001
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 12, 2024
    Manufacturer
    BEUTLICH PHARMACEUTICALS, LLC
    Product Code
    KLE
    UDI-DI
    10723797697822
    PMA / PMN Number
    K973002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ADMINISTRATION OF STEROID AND DISCONTINUE USE OF THE DEVICE, THE PATIENT'S SYMPTOMS ABATED AND TISSUES RETURNED TO NORMAL WITHIN DAYS.

    Description of Event or Problem · 0

    ON THURSDAY JULY 25, 2024 BEUTLICH REGULATORY AFFAIRS RECEIVED INFORMATION FROM A DENTAL OFFICE REQUESTING INGREDIENT INFORMATION FOR THE MEDICAL DEVICE, HURRISEAL. IN SPEAKING WITH THE CALLER, REGULATORY PERSONNEL WAS TOLD THAT THE HURRISEAL DEVICE PRODUCT WAS USED ON A PATIENT (FEMALE, 33 YEARS OLD) WHO WAS HAVING VENEERS APPLIED TO SEVERAL (12) TOP AND FRONT TEETH. IT WAS REPORTED TO BEUTLICH THAT THE PATIENT RECEIVED INITIAL SERVICES ON (B)(6) 2024 AND THE NEXT DAY COMPLAINED TO THE DENTAL OFFICE THAT HER LIP WAS RED AND SWOLLEN AND FELT "WEIRD". THIS MESSAGE WAS RELAYED TO THE DENTIST WHO THOUGHT IT MAY HAVE BEEN SOME KIND OF AN ALLERGIC REACTION AND CALLED IN A MEDROL STEROID PACK FOR THE PATIENT. THE PATIENT CALLED THE DENTAL OFFICE AGAIN LATER ON (B)(6) 2024 STATING HER GUMS WERE NOW "FIRE ENGINE RED" AND SWOLLEN. THE DENTIST REQUESTED THE PATIENT COME IN TO THE OFFICE FOR EXAMINATION AND FOUND THAT THE STEROID PACK HAD RELIEVED THE ISSUE WITH THE PATIENT'S LIP, BUT HER GUMS WERE STILL AFFECTED; RED AND INFLAMED. THE FOLLOWING DAY, (B)(6) 2024 THE PATIENT STATED THAT HER GUMS HAD TURNED A WHITE GRAY COLOR AND WAS SLOUGHING SKIN. ON (B)(6) 2024 THE PATIENT REPORTED THAT HER GUMS WERE RETURNING TO NORMAL AND ON (B)(6) 2024 WAS SEEN BY THE DENTIST WHO RECORDED THAT HER GUMS HAD APPEARED TO BE BACK TO NORMAL. SEVERAL REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE REMAINING DEVICE FOR ADDITIONAL ANALYSIS, BUT IT IS NOT AVAILABLE AT THE TIME OF THIS INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968600 HURRISEAL DENTIN DESENSITIZER DENTIN DESENSITIZER KLE BEUTLICH PHARMACEUTICALS, LLC 12ML F156KP 10723797697822

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention| O HURRISEAL DENTIN DESENSITIZER