BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AH PLUS BIOCERAMIC SEALER STARTER KIT

    MDR report key: 14673304 · Received June 13, 2022

    Report

    Report Number
    2320721-2022-00167
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    June 1, 2022
    Report Date
    August 19, 2022
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    KIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT NOT RECEIVED AT INVESTIGATION SITE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT AHPBIOSEAL MAY HAVE CAUSE SWELLING TO THE PATIENT. CUSTOMER THOUGHT THAT THIS PRODUCT WAS THE CAUSE; PATIENT(S) WERE TREATED AND REPORTEDLY THEY ARE FINE WITH NO PAIN, SYMPTOMS OR SWELLING. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687235 AH PLUS BIOCERAMIC SEALER STARTER KIT RESIN, ROOT CANAL FILLING KIF TULSA DENTAL PRODUCTS LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown