BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADENOTOME

    MDR report key: 19167 · Received January 26, 1995

    Report

    Report Number
    MW1004875
    Event Type
    Malfunction
    Date Received
    January 26, 1995
    Date of Event
    January 19, 1995
    Report Date
    January 24, 1995
    Manufacturer
    V. MUELLER DIV., BAXTER HEALTHCARE CO.
    Product Code
    KBH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SLIDIING PART OF ADENOTOME WHEICH ATTACHES TO BLADE CAME LOOSE LACERATING SOFT PALATE. TWO CHROMIC STITCHES WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADENOTOME KBH V. MUELLER DIV., BAXTER HEALTHCARE CO. RH4330

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other