BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE-GARD MOLAR BITE BLOCK

    MDR report key: 1204673 · Received October 20, 2008

    Report

    Report Number
    3004365956-2008-00061
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Report Date
    October 3, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. EVALUATION REPORT NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: WHITE HANDLE BROKE OFF THE GREEN BITE BLOCK AT THE TIME THE BIT-GARD WAS BEING REMOVED FROM THE PATIENT'S MOUTH. IT DID NOT GO DOWN THE PATIENT'S THROAT. REQUIRED REMOVAL WITH FORCEPS. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1