BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAC PLASTIC MOUTHGUARD MATERIAL

    MDR report key: 771460 · Received October 20, 2006

    Report

    Report Number
    2310178-2006-00504
    Event Type
    Injury
    Date Received
    October 20, 2006
    Report Date
    September 22, 2006
    Manufacturer
    DENTSLPY GAC INTERNATIONAL
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE MOUTHGUARD INVOLVED 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 CONSEQUENCE BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PATIENT POSSIBLY HAD AN ALLERGIC REACTION TO A MOUTHGUARD, AFTER SEVERAL MONTHS OF USE. OUTCOME OF THE EVENT IS NOT KNOWN AFTER MULTIPLE FOLLOW-UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAC PLASTIC MOUTHGUARD MATERIAL DYJ DYJ DENTSLPY GAC INTERNATIONAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other