BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELF LATEX FREE ELASTICS

    MDR report key: 3894081 · Received June 19, 2014

    Report

    Report Number
    2418500-2014-00001
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    ECI
    PMA / PMN Number
    EXEMPT
    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 ELASTOMETRIC 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 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. EVALUATION OF THE DEVICE FOUND THAT THE PRODUCT EXPIRED IN 12/2005.

    Description of Event or Problem · 1

    IN THIS EVENT A PATIENT EXPERIENCED AN ALLERGIC REACTION FROM AN ELASTOMERIC USED AFTER ITS EXPIRATION DATE, THEY REPORTED SWELLING AND IRRITATION TO THE GINGIVA AND CHEEK. MEDICAL ATTENTION WAS NECESSARY AS THE PATIENT WAS PRESCRIBED A STEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362131 ELF LATEX FREE ELASTICS ECI GAC INTERNATIONAL 03-42

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention