BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 1673614 · Received April 29, 2010

    Report

    Report Number
    2515379-2010-00054
    Event Type
    Injury
    Date Received
    April 29, 2010
    Report Date
    March 31, 2010
    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 UNK IF THE NUPRO USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEVELOPED SWELLING OF THE LIPS AND TONGUE AFTER A PROCEDURE WAS PERFORMED USING NUPRO PROPHY PASTE; THE REPORTER IS NOT CERTAIN THAT NUPRO WAS THE PRODUCT USED AS THE CUP WAS PULLED FROM A JAR THAT CONTAINED PASTE FROM DIFFERENT MANUFACTURERS. NO INTERVENTION WAS REQUIRED AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other