BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAC NON LETEC ELESTICS

    MDR report key: 4795832 · Received May 21, 2015

    Report

    Report Number
    2418500-2015-00001
    Event Type
    Injury
    Date Received
    May 21, 2015
    Report Date
    April 22, 2015
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    ECI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RESPONSES AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PARK 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT BETWEEN TWO OR THREE WEEKS AFTER EXPOSURE TO GAC ELASTICS (NON-LATEX), A PT BEGAN EXPERIENCING BURING AND ITCHING OF THE LIPS AND EYES. THE PT TOOK BENADRYL TO COMBAT THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333538 GAC NON LETEC ELESTICS BAND, ELASTIC, ORTHODONTIC ECI GAC INTERNATIONAL 316739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention