BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE-GARD MOLAR BITE BLOCK

    MDR report key: 1673815 · Received April 20, 2010

    Report

    Report Number
    3004365956-2010-00027
    Event Type
    Malfunction
    Date Received
    April 20, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 29, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: WHEN THE DOCTOR ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT'S MOUTH, ITS SNAPPED AT THE JOINT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE-GARD MOLAR BITE BLOCK BITE BLOCK JXL TELEFLEX MEDICAL NA 02J0902663

    Patients

    Seq Age Sex Outcome Treatment
    1