BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION

    MDR report key: 3530243 · Received December 5, 2013

    Report

    Report Number
    1718912-2013-00025
    Event Type
    Other
    Date Received
    December 5, 2013
    Report Date
    December 3, 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

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 1718912-2013-00025. BIOTENE DRY MOUTH ORAL RINSE IS MFR IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (PT'S FRIEND) AND DESCRIBED THE OCCURRENCE OF GAGGING IN A (B)(6) OLD MALE PT WHO RECEIVED ORAL MOISTURISERS (BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) MOUTHWASH FOR DRY MOUTH. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH, HOSPITALIZATION, LEUKEMIA, RADIATION THERAPY, STEM CELL TRANSPLANT AND TASTE ALTERATION. CONCURRENT MEDICATIONS INCLUDED CANCER CHEMOTHERAPY (CHEMOTHERAPY). ON AN UNK DATE, THE PT STARTED ORAL MOISTURISERS (DENTAL). AT AN UNK TIME AFTER STARTING ORAL MOISTURISERS, THE PT EXPERIENCED GAGGING. THE PT WAS HOSPITALIZED ON (B)(6) 2013 (REASON NOT SPECIFIED). THIS CASE WAS REPORTED BY A FRIEND OF A CONSUMER WHO HAS BEEN BATTLING LEUKEMIA SINCE THIS PAST MARCH. IT WAS REPORTED THAT WITH THE TYPE OF BAD LEUKEMIA HE HAS, HE ONLY HAS A 30% CHANCE TO SURVIVE. CONSUMER'S TASTE IS ALTERED BECAUSE OF THE CHEMOTHERAPY AND THE RADIATION AND NOTHING TASTES GOOD TO HIM AND HE GAGS ON A LOT OF PRODUCTS BECAUSE OF HIS CONDITION. CONSUMER IS BACK IN THE HOSPITAL AS OF YESTERDAY ((B)(6) 2013). CONSUMER HAD A STEM CELL TRANSPLANT AND THE TRANSPLANT IS "FIGHTING HIM AND DRYING OUT HIS BODY FROM THE INSIDE OUT". CONSUMER REPORTED THAT HER FRIEND TRIED BIOTENE DRY MOUTH ORAL RINSE AND HE GAGS WHEN HE USED IT. CONSUMER IS ABLE TO USE BIOTENE MOISTURIZING MOUTH SPRAY WITHOUT ANY PROBLEMS. CONSUMER WAS GOING TO SEE IF HE HAD TRIED BIOTENE DRY MOUTH TOOTHPASTE AND SHE WAS GOING TO SUGGEST HE USES BIOTENE ORALBALANCE GEL. TREATMENT WITH ORAL MOISTURISERS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631725 BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION ORAL MOISTURISERS LFD GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization CHEMOTHERAPY ( UNK - UNK)