BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEA-BOND DENTURE ADHESIVE

    MDR report key: 458912 · Received May 9, 2003

    Report

    Report Number
    1450238-2002-00001
    Event Type
    Other
    Date Received
    May 9, 2003
    Date of Event
    July 7, 2002
    Report Date
    April 15, 2003
    Manufacturer
    COMBE, INC.
    Product Code
    KOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER SWALLOWED SEA-BOND DENTURE ADHESIVE WHILE EATING. PT WENT TO LOCAL HOSPITAL EMERGENCY ROOM REPORTING PAIN AND NAUSEA. A NASOGASTRIC TUBE WAS PLACED. PT WAS ADMITTED TO HOSPITAL FOR 6 DAYS, DURING WHICH THEIR EATING AND BOWEL FUNCTIONS RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA-BOND DENTURE ADHESIVE DENTURE ADHESIVE KOM COMBE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization LEVOXYL, CLONAZEPAM, NOVOLIN VERAPAMIL.