BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVIS DOUBLE BITE MOUTH GAG

    MDR report key: 42361 · Received October 4, 1996

    Report

    Report Number
    1932180-1996-00081
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 6, 1996
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    KBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE WELD ON THIS MOUTH GAG IS CRACKED UNDERNEATH THE LEVER AND DOES NOT PROVIDED TENSION FOR RATCHET. IT WILL NOT HOLD THE TONGUE BLADE IN PLACE. ANOTHER MOUTH GAG WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVIS DOUBLE BITE MOUTH GAG MOUTH GAG KBN STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO