BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION

    MDR report key: 3514515 · Received November 29, 2013

    Report

    Report Number
    1718912-2013-00024
    Event Type
    Death
    Date Received
    November 29, 2013
    Report Date
    November 27, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT DIED FROM DEATH (CAUSE UNK). IT IS UNK WHETHER AN AUTOPSY WAS PERFORMED. THE MFR'S REPORT NUMBER FOR THIS CASE IS 1718912-2013-00024. BIOTENE DRY MOUTH ORAL RINSE IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY THE CONSUMER (PT'S DAUGHTER) AND DESCRIBED THE OCCURRENCE OF DEATH (CAUSE UNK) IN A FEMALE PT WHO RECEIVED ORAL MOISTURIZERS (BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION)) MOUTHWASH FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH AND LOU GEHRIG'S DISEASE. ON AN UNK DATE, THE PT STARTED ORAL MOISTURIZERS (DENTAL). AT AN UNK TIME AFTER STARTING ORAL MOISTURIZERS, THE PT EXPERIENCED MUCH SALIVA AND SIDE EFFECTS WERE BAD. THE REPORTER STATED THAT BIOTENE ORAL RINSE CAUSED HER MOTHER TO HAVE SO MUCH SALIVA. THE DAUGHTER REPORTED IT WAS MASSIVE WHERE SHE HAD TO CALL AN EAR NOSE AND THROAT SPECIALIST (ENT) AND WAS ADVISED TO TAKE HER MOTHER TO THE HOSPITAL. WHEN THE PT GOT TO THE HOSPITAL, THEY ENDED UP PUTTING A FEEDING TUBE INTO HER. ON AN UNK DATE THE PT UNDERWENT A FEEDING TUBE PLACEMENT. ON AN UNK DATE THE PT DIED (CAUSE OF DEATH UNK). THE PT WAS HOSPITALIZED. AT THE TIME OF REPORTING, THE EVENTS WERE FATAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621657 BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION ORAL MOISTURIZERS LFD GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H