BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETAINER

    MDR report key: 3963455 · Received July 24, 2014

    Report

    Report Number
    MW5037451
    Event Type
    Injury
    Date Received
    July 24, 2014
    Manufacturer
    RAINTREE ESSEX
    Product Code
    JEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LIPS HAD BLISTERS, PEELED, PUFFED THREE MONTHS, BIG BOILS ON LIPS NON STOP. WENT EMERGENCY ROOM THEY DIDN'T KNOW WHAT TO DO. DATES OF USE: SUMMER 2007 - (B)(6). DIAGNOSIS OR REASON FOR USE: RETAINER - HOLDING TEETH IN PLACE. EVENT ABATED AFTER USE STOPPED OR DOSAGE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434981 RETAINER RETAINER JEP RAINTREE ESSEX

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L| O| S PRESCRIPTION: NONE.