BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERRA

    MDR report key: 1772150 · Received July 22, 2010

    Report

    Report Number
    2515379-2010-00097
    Event Type
    Injury
    Date Received
    July 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBI
    PMA / PMN Number
    K072713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS NOT DEFINITIVELY KNOWN IF THE INTERRA 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 UPON FABRICATION OF AN INTERRA NIGHTGUARD, THE PT DEVELOPED REDNESS AND ITCHING OF THE GINGIVA. THE NIGHTGUARD WAS REMOVED FOR 24 HOURS AND THE SYMPTOMS RESOLVED. THE SYMPTOMS REAPPEARED ONCE THE NIGHTGUARD WAS REINTRODUCED. NO INTERVENTION WAS REQUIRED TO TREAT THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERRA EBI DENTSPLY CAULK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other