BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA BOND DENTURE ADHESIVE LOWER WAFERS

    MDR report key: 2655608 · Received July 6, 2012

    Report

    Report Number
    1450238-2012-00001
    Event Type
    Injury
    Date Received
    July 6, 2012
    Date of Event
    April 28, 2012
    Report Date
    July 3, 2012
    Manufacturer
    COMBE LABORATORIES
    Product Code
    KXW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WILL EVALUATE RETURNED PRODUCT SAMPLE UPON RECEIPT FROM COMBE WHITE PLAINS. WILL REPORT QC EVAL RESULTS TO FDA WHEN COMPLETE.

    Description of Event or Problem · 1

    INITIAL REPORTER STATED THAT HE BELIEVES THAT HIS DIFFICULTY BREATHING AND SUBSEQUENT ADMITTANCE TO THE HOSPITAL WAS A RESULT OF HIS USE OF (B)(4) DENTURE ADHESIVE. IN ERROR, THIS CASE WAS NOT IMMEDIATELY BROUGHT TO THE ATTENTION OF THE MANAGER OF PRODUCT INTEGRITY BY THE CONSUMER RESOURCES AGENT WHO RECEIVED THE CALL ON (B)(4) 2012. ON (B)(6) 2012, COMBE INCORPORATED RECEIVED A LETTER FROM INITIAL REPORTER STATING THAT HE USED (B)(4) WHICH MADE HIS MOUTH STICKY, MAKING IT DIFFICULT TO SWALLOW AND BREATHE. HE REQUESTED A REFUND OF PURCHASE PRICE. ON (B)(6) 2012, THE INITIAL REPORTER CALLED COMBE TO INQUIRE ABOUT REFUND. THE CONSUMER RESOURCES AGENT ASKED IF HE REQUIRED MEDICAL ATTENTION FOR HIS EXPERIENCE AND HE REPLIED THAT HE HAD BEEN IN THE (B)(6) HOSPITAL AND WAS RELEASED ON (B)(6) 2012. HE SAID HE THINKS THAT HE INHALED SOME OF THE ADHESIVE. HE SAID HE IS DOING WELL NOW. AGENT REMINDED HIM TO RETURN THE UNUSED WAFERS. MANAGER OF PRODUCT INTEGRITY AT COMBE OBSERVED THE RETURNED WAFERS ON (B)(4) 2012, REPLAYED THE (B)(4) 2012 CALL AND NOTED THE REPORTED HOSPITALIZATION. CALLED CONSUMER ON (B)(4) 2012 AND SENT LETTER REQUESTING FURTHER INFO. HE HAS NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA BOND DENTURE ADHESIVE LOWER WAFERS KXW COMBE LABORATORIES R12A065

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization CORTICOSTEROID