BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE-GARD MOLAR BITE BLOCK

    MDR report key: 1235742 · Received November 18, 2008

    Report

    Report Number
    3004365956-2008-00069
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    October 29, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN SENT TO THE MFR, BUT INVESTIGATION REPORT IS NOT AVAILABLE YET. INVESTIGATION IS ONGOING, AND A FOLLOW UP REPORT WILL BE SENT AS SOON AS IS AVAILABLE.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED AS: THE GREEN PLASTIC END BECAME DISLODGED FROM THE WHITE PLASTIC ARM. IT WAS RETRIEVED FROM THE PT'S PHARYNX USING A MAGILL FORCEPS. THIS REPORT IS THE SECOND OF TWO SEPARATE INCIDENTS REPORTED. NO PT INJURY REPORTED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE-GARD MOLAR BITE BLOCK BITE GARD JXL TELEFLEX MEDICAL 3007920407

    Patients

    Seq Age Sex Outcome Treatment
    1