BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX C+

    MDR report key: 1971396 · Received January 12, 2011

    Report

    Report Number
    1036212-2010-00123
    Event Type
    Injury
    Date Received
    January 12, 2011
    Report Date
    December 16, 2010
    Manufacturer
    DENTSPLY RAINTREE ESSIX GLENROE
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE ESSIX C+ (B)(4) 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 IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PATIENT "HAS SEVERE ALLERGIC REACTIONS WHICH APPEAR TO BE TRIGGERED BY AN ORTHODONTIC RETAINER MANUFACTURED FROM (B)(4) PRODUCED BY YOUR COMPANY." THE REPORT FURTHER STATES THAT THE REACTIONS APPEAR LINKED TO OTHER SERIOUS SYMPTOMS THE PATIENT HAS BEGUN TO SUFFER, INCLUDING PSYCHIATRIC ONES. THERE IS NO INFO REGARDING THE DURATION OF THE REACTION, OR WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSIX C+ MQC DENTSPLY RAINTREE ESSIX GLENROE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other