BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACEBOW

    MDR report key: 7005152 · Received November 6, 2017

    Report

    Report Number
    2016150-2017-00005
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS RETURNED AND EVALUATED. THE PRODUCT MET SPECIFICATIONS AND PACKAGING WARNS OF PRODUCT CONTAINING NICKLE AND CHROMIUM AND SHOULD NOT BE USED ON INDIVIDUALS WITH ALLERGIC SENSITIVITY TO THESE METALS. TO DATE THE PATIENT IS DOING BETTER.

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A PATIENT HAD AN ALLERGIC REACTION TO THE FACEBOW; HOWEVER NO FURTHER SPECIFIC INFORMATION HAS BEEN RECEIVED AT THIS TIME. ATTEMPTS ARE BEING MADE TO GET FURTHER INFORMATION AND WILL AN UPDATE.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT A PATIENT HAD AN ALLERGIC REACTION TO FACEBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784394 FACEBOW FACEBOW DZB ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other