BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 3030609 · Received March 21, 2013

    Report

    Report Number
    2515379-2013-00007
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    PMA / PMN Number
    K912945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 FR 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.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE USE OF NUPRO PROPHYLAXIS PASTE; NO INTERVENTION WAS NECESSARY. THE REPORT STATES THAT THE PATIENT'S GUM TISSUE WAS VERY RED AND SORE AS A RESULT OF THE MATERIALS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117792 NUPRO PROPHY PASTE EJR DENTSPLY PROFESSIONAL 12122302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other