BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPEX PROPHY PASTE

    MDR report key: 11853037 · Received May 19, 2021

    Report

    Report Number
    2424472-2021-00027
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    May 12, 2021
    Manufacturer
    DENTSPLY LLC
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    WHILE USING TOPEX PROPHY PASTE (FLAVOR UNKNOWN) ON A PATIENT, DURING HER CLEANING SHE HAD A SEVERE ALLERGIC REACTION. SHE HAS A ALPHA GAL ALLERGY TO ANY MAMMAL INGREDIENTS INCLUDING DAIRY. HER DENTAL HYGIENIST WAS NOTIFIED BUT HAVING ALPHA GAL (MAMMAL ALLERGY) HER REACTION WAS DELAYED. SHE HAD A CLEANING 3-4PM AND WOKE UP 5AM THE NEXT MORNING COVERED IN HIVES. SHE WAS TRYING TO TROUBLE SHOOT WHAT COULD HAVE CAUSED IT, BESIDE SUSPECTING A RECENT CHANGE IN A PRESCRIPTION DRUG STARTED ALMOST 2 WEEKS PRIOR. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743508 TOPEX PROPHY PASTE AGENT, POLISHING, ABRASIVE, ORAL CAVITY EJR DENTSPLY LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other