BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWLEY RETAINER

    MDR report key: 5565146 · Received April 8, 2016

    Report

    Report Number
    1036212-2016-00002
    Event Type
    Injury
    Date Received
    April 8, 2016
    Report Date
    March 10, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    DYJ
    PMA / PMN Number
    NA
    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 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. AT THIS TIME, WE ARE UNSURE IF THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO HIS HAWLEY RETAINER. WHILE WEARING THE RETAINER, THE PATIENT SUFFERS FROM HEADACHES AND HIS UPPER PALATE IS ITCHY. WHEN HE REMOVES THE RETAINER, THE HEADACHES AND ITCHINESS STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218564 HAWLEY RETAINER RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ RAINTREE ESSIX INC. NA 626842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other