BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTRACTION FACEMASK

    MDR report key: 2987613 · Received February 26, 2013

    Report

    Report Number
    2418500-2013-00001
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    DZB
    PMA / PMN Number
    K000358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE DEVICE 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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE 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 THE PT EXPERIENCED AN ALLERGIC REACTION TO THE PROTRATION FACEMASK ON THEIR CHIN. NO MEDICAL ATTENTION WAS NECESSARY AND THE AFFECTED CLEARED UP WITH IN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81259 PROTRACTION FACEMASK DZB GAC INTERNATIONAL 0711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other