BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA-BOND WAFERS

    MDR report key: 3381560 · Received September 27, 2013

    Report

    Report Number
    MW5032069
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 26, 2013
    Product Code
    KXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED SEA BOND WAFERS ON MY DENTURES AND HAD HEART PALPITATIONS. I HAD TO USE 4 WAFERS AS MY GUMS AND FALSE TEETH WERE HURTING ME. I WANT YOU TO PUT 4 WAFERS IN YOUR MOUTH AND HAVE YOUR PULSE TAKEN BEFORE AND AFTER AND YOU WILL SEE YOUR HEART RATE CHANGE. A SAFE PRODUCT WOULD NOT CAUSE THIS SO THE WAFERS CONTAIN HARMFUL SUBSTANCES. AFTER SEEING THESE HARMFUL EFFECTS I WANT YOU TO ISSUE AN ORDER FOR SEA BOND TO CEASE SELLING A DANGEROUS PRODUCT; AND I WANT A WHISTLE BLOWERS FEE FROM THE BILLION DOLLAR FINE THEY PAY FOR SELLING AN DEFECTIVE PRODUCT THAT IS HARMFUL TO THE BODY. I PERSONALLY MADE THE "TEST" ON MY OWN BODY AS NOTED ABOVE. THIS IS A DANGEROUS PRODUCT. WHEN 4 WAFERS CAUSE SUCH HARMFUL RESULT; EVEN USING ONE HAS THE SAME DANGEROUS SUBSTANCE IN IT. DATES OF USE: 5 YEARS. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489842 SEA-BOND WAFERS DENTURE ADHESIVE KXX
    489843 SEA-BOND WAFERS DENTURE ADHESIVE KXX
    489844 SEA-BOND WAFERS DENTURE ADHESIVE KXX
    489845 SEA-BOND WAFERS DENTURE ADHESIVE KXX

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other