BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAFIX SPECIAL DEN. ADHESIVE

    MDR report key: 130354 · Received October 30, 1997

    Report

    Report Number
    MW1012429
    Event Type
    Other
    Date Received
    October 30, 1997
    Date of Event
    June 1, 1997
    Report Date
    October 29, 1997
    Manufacturer
    HOGIL PHARMACEUTICAL CORP.
    Product Code
    KOQ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR TELEPHONED SMITHKLINE BEECHAM, AND WAS INFORMED THAT THIS PRODUCT WAS SOLD TO HOGIL PHARMACEUTICAL CORP. ON APRIL 1, 1996 AND THAT THEY WERE NOW THE MFR. THE RPTR HAS 2 QUESTIONS. WHO MANUFACTURES THIS PRODUCT? WHAT ARE THE INGREDIENTS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAFIX SPECIAL DEN. ADHESIVE * KOQ HOGIL PHARMACEUTICAL CORP. * 70313

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other