BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH PULL HEADGEAR

    MDR report key: 3746520 · Received April 11, 2014

    Report

    Report Number
    2016150-2014-00026
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZB
    PMA / PMN Number
    K902645
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT SOUGHT MEDICAL ATTENTION WITH A DERMATOLOGIST AND WAS GIVEN A CREAM FOR THE REACTION. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED IRRITATION, FRICTION AND PAIN AFTER WEARING THE HIGH PULL HEADGEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220595 HIGH PULL HEADGEAR EXTRAORAL ORTHODONTIC HEADGEAR DZB ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other| R