BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA-BOND DENTURE ADHESIVE UPPER WAFERS

    MDR report key: 1624484 · Received March 4, 2010

    Report

    Report Number
    1450238-2010-00001
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 12, 2010
    Manufacturer
    COMBE INCORPORATED
    Product Code
    KXW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HAVE NOT RECEIVED MEDICAL RECORDS SUBSTANTIATING THE REPORTED BREATHING DIFFICULTY WAS CAUSED BY SEA BOND. RESULTS OF EVALUATION OF RETAINED SAMPLE OF LOT R09L010 SHOW NO ISSUES THAT SUGGEST ANY DEFECTS ASSOCIATED WITH THE LOT.

    Description of Event or Problem · 1

    INITIAL REPORTER STATED THAT SHE BELIEVES THAT HER DIFFICULTY BREATHING AND SUBSEQUENT ADMITTANCE TO THE HOSPITAL FROM (B) (6) 2010 THROUGH (B) (6) 2010, WAS A RESULT OF HER USE OF SEA BOND DENTURE ADHESIVE. SHE SAID SHE EXPERIENCED A SIMILAR EPISODE IN (B) (6) 2009 AND WAS ADMITTED TO THE HOSPITAL FOR 1 DAY. SHE SAID THE HOSPITAL DIAGNOSED HER WITH ALLERGY, BRONCHITIS OR ASTHMA ATTACK. SHE WAS TREATED WITH A BREATHING MACHINE EVERY 4 HOURS WHILE IN THE HOSPITAL. WAS GIVEN A BREATHING MACHINE TO USE AT HOME, BUT HAS NOT USED IT. SHE SATED THAT SHE HAS USED SEA BOND ON HER UPPER DENTURE SINCE (B) (6) 2009, APPLIES IT DAILY AND SLEEPS WITH HER DENTURE IN HER MOUTH. SHE USED SEA BOND THIS WAY DURING HER HOSPITAL STAY AS WELL. SHE SAID SHE SAW HER PRIMARY CARE PHYSICIAN (B) (6) 2010 AND HE TOLD HER SHE HAD A REACTION TO SEA BOND. SHE SAID HE ADVISED HER TO STOP USING SEA BOND AND PRESCRIBED SINGULAIR. SHE SAID SHE HAS NOT EXPERIENCED BREATHING PROBLEMS SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA-BOND DENTURE ADHESIVE UPPER WAFERS KXW COMBE INCORPORATED R09L010

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O