BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON BITEGARD

    MDR report key: 3032773 · Received March 29, 2013

    Report

    Report Number
    3004365956-2013-00099
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 2, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY REPORT NUMBER: (B)(4) (FROM MAUDE EVENT REPORT). A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF THE DEFECTIVE SAMPLE OR A PICTURE OF IT. IN ORDER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE FOR THE DEFECT REPORTED THE PHYSICAL SAMPLE OR A PICTURE OF THE DEVICE IS NECESSARY. ROOT CAUSE - UNKNOWN.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE COMPLAINT ALLEGES THAT BITE BLOCK BROKE WHILE IN THE PATIENT'S MOUTH. THE REPORT INDICATES THAT THE BLOCK WAS ABLE TO BE REMOVED SAFELY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131087 HUDSON BITEGARD BITE BLOCK JXL TELEFLEX MEDICAL 02C1200567

    Patients

    Seq Age Sex Outcome Treatment
    1