BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIE

    MDR report key: 2031012 · Received March 16, 2011

    Report

    Report Number
    2515379-2011-00003
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SHEALTHCARE INC.
    Product Code
    ELW
    PMA / PMN Number
    K030414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE IMPRESSION MATERIAL 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 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

    IN THIS EVENT IT WAS REPORTED THAT A PT DEVELOPED SORES IN THEIR MOUTH AFTER HAVING AN IMPRESSION RECORDED WITH GENIE IMPRESSION MATERIAL. THERE IS NO INDICATION THAT MEDICAL INTERVENTION WAS NECESSARY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENIE ELW SHEALTHCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other