BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA BOND DENTURE ADHESIVE

    MDR report key: 24241 · Received August 9, 1995

    Report

    Report Number
    MW1006676
    Event Type
    Injury
    Date Received
    August 9, 1995
    Date of Event
    May 1, 1995
    Report Date
    July 26, 1995
    Manufacturer
    COMBE INC.
    Product Code
    KOP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IS AN UPPER DENTURE ADHESIVE PAD, WHICH IS DIPPED INTO WARM WATER THEN APPLIED TO THE UNDERSIDE OF THE DENTURE, PRESSED INTO PLACE AND TRIMMED. THE PT WAS EATING WITH HER DENTURE IN AND THE PRODUCT SLIPPED TO THE REAR OBSCURING HER ESOPHAGUS AND TRACHEA. SHE HAD TO REMOVE THE DENTURE AND THE FOOD BOLUS TO RETRIEVE THE PRODUCT. HAD SHE NOT THE PRESENCE OF MIND TO ACCOMPLISH THESE MANUEVERS OR HAD SHE NOT BEEN PHISICALLY ABLE TO, SHE COULD HAVE EXPIRED. BECAUSE THIS PRODUCT IS DIRECTED AT THE ELDERLY WHO MAY NOT BE ABLE TO REMOVE A DISLODGED ADHESIVE PAD, RPTR BELIEVES THIS PRODUCT SHOULD BE CRITICALLY EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA BOND DENTURE ADHESIVE DENTURE ADHESIVE-UPPER KOP COMBE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R