BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK

    MDR report key: 1675634 · Received April 27, 2010

    Report

    Report Number
    1675634
    Event Type
    Malfunction
    Date Received
    April 27, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 27, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KBN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE MOUTH GAG WAS PLACED IN PATIENT'S MOUTH FOR SURGICAL PROCEDURE. THE INSTRUMENT SNAPPED APART WHILE STILL IN PATIENT'S MOUTH. SUDDENLY, THE MOUTH CLOSED. DR. EXAMINED TEETH AND MOUTH. THERE WAS NO APPARENT INJURY NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK GAG, MOUTH PIECE KBN TELEFLEX MEDICAL 764FG *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR