BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUTH GAG

    MDR report key: 44764 · Received October 25, 1996

    Report

    Report Number
    MW1010155
    Event Type
    Malfunction
    Date Received
    October 25, 1996
    Date of Event
    October 3, 1996
    Report Date
    October 7, 1996
    Manufacturer
    DITTMAN & PENN CORP.
    Product Code
    KBN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MOUTH GAG BROKE ON PLACEMENT IN PT'S MOUTH. PT REQUIRED SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUTH GAG MOUTH GAG KBN DITTMAN & PENN CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Other