BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON Q

    MDR report key: 3558340 · Received January 7, 2014

    Report

    Report Number
    2016150-2014-00002
    Event Type
    Injury
    Date Received
    January 7, 2014
    Report Date
    December 11, 2013
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DYW
    PMA / PMN Number
    K052477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE ORTHODONTIST IDENTIFIED MULTIPLE CATALOG NUMBERS ASSOCIATED WITH THE INCIDENT, NO LOT NUMBERS WERE PROVIDED; THEREFORE, NO CATALOG NUMBERS OR LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE CATALOG NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDE ONE (1) EACH OF CATALOG NUMBERS 491-6411, 491-6410, 491-6421, 491-6420, 491-6435, 491-6434, 491-6441, 491-6440, 491-6451, 491-6450, 491-6461, 491-6460, 491-6471, 491-6470, 491-6485, 491-6484, 491-6491, 491-6490, 438-2190, 438-2191, 438-0015, AND 438-0016. DURING THE HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH AN ALLERGY TO COPPER. THE ORTHODONTIST DESCRIBED THE REACTION AS "THE BODY WAS FIGHTING ITSELF". THE PATIENT HAD BECOME VERY WEAK AND WAS IN A WHEELCHAIR WHEN VISITING THE ORTHODONTIST FOR REMOVAL OF THE BRACKETS AND WIRE. NO INFORMATION WITH REGARD TO DIAGNOSTIC TESTING OR PRESCRIPTION MEDICATIONS WAS PROVIDED. THE ORTHODONTIST REPORTED THAT THE DAMON Q BRACKETS AND THE DAMON COPPER NITI ARCHWIRE WERE NOT BELIEVED TO BE THE REASON FOR THE REACTION. THE PATIENT DID NOT EXPERIENCE ANY REDNESS OR SWELLING IN THE MOUTH. IT WAS DETERMINED BY THE HOSPITAL THAT THE LIKELY CAUSE OF THE REACTION WAS FROM COPPER IN THE WATER PIPES AT HOME OR OTHER DOMESTIC SOURCES; HOWEVER, THE DAMON Q BRACKETS AND THE DAMON COPPER NITI ARCHWIRE WERE REMOVED AS A PRECAUTIONARY MEASURE. IT WAS CONFIRMED THAT THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    AN ORTHODONTIST ALLEGED THAT A PATIENT HAD EXPERIENCED AN ALLERGIC REACTION TO COPPER AND WAS HOSPITALIZED WHILE WEARING THE DAMON Q BRACKETS AND DAMON COPPER NITI ARCHWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10460 DAMON Q BRACKET, METAL, ORTHODONTIC DYW ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| O| R DAMON COPPER NITI ARCHWIRE