BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON BITE-GARD ORAL BITE BLOCK, INTL

    MDR report key: 2452213 · Received February 7, 2012

    Report

    Report Number
    3004365956-2012-00043
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 23, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW OF REPORTED BATCH NUMBERS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT NUMBERS IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. NO ADD'L DOCUMENTS WERE REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS MOMENT SINCE THE DEFECTIVE SAMPLE IS NOT AVAILABLE FOR EVAL. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED WITH THE INFO PROVIDED. IN ORDER TO DETERMINE A ROOT CAUSE FOR THE COMPONENTS SEPARATION, IT IS NECESSARY TO EVALUATE THE PHYSICAL SAMPLE, IF IT IS PROVIDED OR A PICTURE THAT CAN GIVE US ENOUGH INFO TO PERFORM AN INVESTIGATION, THIS COMPLAINT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE GREEN BITE BLOCK BECAME DETACHED IN THE PT'S MOUTH. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON BITE-GARD ORAL BITE BLOCK, INTL BITE-GARD BWF TELEFLEX MEDICAL 02C1001857 OR 02B1000808

    Patients

    Seq Age Sex Outcome Treatment
    1