BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA-BOND DENTURE ADHESIVE UPPER WAFERS

    MDR report key: 1546840 · Received November 25, 2009

    Report

    Report Number
    1450238-2009-00001
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    September 28, 2009
    Report Date
    November 4, 2009
    Manufacturer
    COMBE INC.
    Product Code
    KOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO GET ANY FURTHER INFO FROM THE INITIAL REPORTER INCLUDING UNUSED PRODUCT AND MEDICAL RECORDS SUBSTANTIATING THE STROKE IN SPITE OF ATTEMPTS TO REACH HIM BY PHONE AND MAIL. RESULTS OF EVALUATION OF RETAINED SAMPLE AND BATCH RECORDS OF LOT R09B133 SHOW NO ISSUES THAT SUGGEST ANY DEFECTS ASSOCIATED WITH THE LOT.

    Description of Event or Problem · 1

    INITIAL REPORTER STATED THAT HE BELIEVES THAT HIS WIFE, WHO HAS BEEN RECOVERING FROM A HEART ATTACK IN A HOSP IN 2009, CHOKED ON SEA BOND DENTURE ADHESIVE WAFERS RESULTING IN A STROKE. THE REPORTER SAID THAT HE WAS NOT PRESENT WHEN A HOSP ATTENDANT MISAPPLIED THE SEA BOND ADHESIVE TO HIS WIFE'S DENTURES BY USING 2 OR 3 UNCUT WAFERS TO COMPENSATE FOR HER ILL-FITTING DENTURES. HE SAID THAT AS THE HOSP STAFF ATTEMPTED TO CLEAR THE EXCESS ADHESIVE FROM HER MOUTH/THROAT, SHE SUFFERED A STROKE AND REMAINS IN THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA-BOND DENTURE ADHESIVE UPPER WAFERS KOM COMBE INC. R09B133

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other