BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI BITE BLOCK

    MDR report key: 2973888 · Received February 13, 2013

    Report

    Report Number
    MW5029038
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 13, 2013
    Manufacturer
    TELEFLEX
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BITE BLOCK BROKE IN PATIENT'S MOUTH, REMOVED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64278 HUDSON RCI BITE BLOCK BITE BLOCK JXL TELEFLEX 02C1200567

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR