BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE-GARD MOLAR BITE BLOCK

    MDR report key: 1722253 · Received June 2, 2010

    Report

    Report Number
    3004365956-2010-00071
    Event Type
    Malfunction
    Date Received
    June 2, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 6, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: DEVICE BROKE DURING USE. THE GREEN PART OF THE DEVICE WAS LEFT IN BACK OF PATIENT'S MOUTH WHEN IT BROKE. BROKEN PART RETRIEVED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE-GARD MOLAR BITE BLOCK BITE-GARD MOLAR BITE BLOCK JXL TELEFLEX MEDICAL NA 02G0900707

    Patients

    Seq Age Sex Outcome Treatment
    1