BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 872380 · Received June 28, 2007

    Report

    Report Number
    2515379-2007-00131
    Event Type
    Injury
    Date Received
    June 28, 2007
    Report Date
    May 29, 2007
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    PMA / PMN Number
    K912945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE NUPRO 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. A DHR REVIEW WAS CONDUCTED WITH NO ABNORMALITIES NOTED. FURTHER INFORMATION PERTAINING TO THIS EVENT WILL BE REPORTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH KNOWN ALLERGIES EXPERIENCED INFLAMMATION AND SORENESS OF THE TONGUE AFTER A PROCEDURE WAS PERFORMED USING NUPRO PROPHY PASTE; THE TONGUE WAS ALSO DESCRIBED AS HAVING A ROUGH TEXTURE. MEDICAL TREATMENT WAS REQUIRED AS A RESULT, THOUGH THE TYPE OF TREATMENT ADMINISTERED IS UNKNOWN AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPRO PROPHY PASTE EJR DENTSPLY PROFESSIONAL NA 06120503

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention