BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 3139829 · Received May 20, 2013

    Report

    Report Number
    2515379-2013-00023
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    PMA / PMN Number
    K912945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    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 IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT DEVELOPED A RASH ON THEIR TONGUE AND A "LUMP IN THROAT" AFTER A TREATMENT PROCEDURE USING NUPRO PROPHY PASTE. THE PATIENT WAS ADMINISTERED ZYRTEC AND THE SYMPTOMS ABATED AFTER 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223190 NUPRO PROPHY PASTE EJR DENTSPLY PROFESSIONAL 10090201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention