BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX + PLASTIC 80 CT .040 (1 MM) -125MM CIRCLE

    MDR report key: 5494275 · Received March 10, 2016

    Report

    Report Number
    1036212-2016-00001
    Event Type
    Injury
    Date Received
    March 10, 2016
    Report Date
    February 9, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED 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 PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT EXPERIENCED AN ALLERGIC REACTION TO A RETAINER FASHIONED FROM ESSIX+ PLASTIC MATERIAL. THE PATIENT EXPERIENCED REDNESS OF THE LIPS AND BLISTERS. THE SYMPTOMS APPEARED GRADUALLY FROM THE DATE THE PATIENT BEGAN WEARING THE RETAINER. THE PATIENT SAW A PEDIATRICIAN AND A DERMATOLOGIST. BOTH MEDICAL PROFESSIONAL PROVIDED AN OTC AND PRESCRIPTION OINTMENTS THAT DID NOT RESOLVE THE PATIENT'S SYMPTOMS. THE DENTIST SUGGESTED THE PATIENT STOP USING THEIR ESSIX RETAINER AND WITHIN 48 HOURS, THE SYMPTOMS HAD DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149656 ESSIX + PLASTIC 80 CT .040 (1 MM) -125MM CIRCLE MOUTHGUARD, PRESCRIPTION MQC RAINTREE ESSIX INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention