BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSBOND PLUS SELF ETCHING PRIMER

    MDR report key: 599787 · Received May 6, 2005

    Report

    Report Number
    2020467-2005-00004
    Event Type
    Injury
    Date Received
    May 6, 2005
    Date of Event
    April 1, 2005
    Report Date
    April 27, 2005
    Manufacturer
    3M UNITEK
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORTHODONTIST STATED THAT THE BRACKETS, ALONG WITH THE ARCHWIRE, DETACHED FROM THE PATIENT'S TEETH BECAUSE OF AN ADHESIVE-BOND FAILURE WHICH HE ATTRIBUTED TO THE ETCHANT/PRIMER. AS A RESULT, THE ARCHWIRE LODGED IN THE PATIENT'S THROAT. PATIENT WAS TAKEN TO AN ACCIDENT & EMERGENCY HOSPITAL WHERE THE ARCHWIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSBOND PLUS SELF ETCHING PRIMER ORTHODONTIC ETCHANT/PRIMER DYH 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ORTHODONTIC ADHESIVE, BRACKETS AND ARCHWIRE| THERAPY DATE:UNKNOWN