BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 3530284 · Received December 5, 2013

    Report

    Report Number
    1718912-2013-00027
    Event Type
    Other
    Date Received
    December 5, 2013
    Report Date
    December 4, 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

    (B)(6) REPORTED VIA PHONE ON DECEMBER 2, 2013: CONSUMER'S PRIMARY REASON FOR HER CALL WAS TO FIND OUT WHY THE BIOTENE MOISTURIZING MOUTH SPRAY HAD BEEN RECALLED. SHE WAS CONCERNED ABOUT THE RECALL BECAUSE SHE HAD BEEN ADMITTED INTO THE HOSPITAL THREE DIFFERENT TIMES IN THE LAST YEAR FOR FIVE DAYS EACH TIME. CONSUMER COULD NOT PROVIDE THE SPECIFIC DATES OF HOSPITALIZATION. SHE REPORTED THAT EACH TIME SHE WAS ADMITTED INTO THE HOSPITAL SHE KIND OF PASSED OUT. SHE STATED SHE WAS EXPERIENCING NAUSEA AND CHEST PAIN. SHE REPORTED THAT SHE PUSHED HER LIFE ALERT BUTTON AND WAS TAKEN BY AMBULANCE. SHE STATED THAT SHE WAS DIAGNOSED WITH BLOCKAGE IN HER ARTERY IN HER LEFT LEG. SHE REPORTED THAT SHE HAD TO HAVE A LEFT FEMORAL BYPASS. SHE STATED THAT THEY OPENED THE ARTERY IN HER LEFT LEG WITH STENTS AND BALLOONS. SHE REPORTED THAT SHE DID ADVISE HER DOCTORS THAT SHE WAS USING BIOTENE. SHE STATED THAT NO ONE SEEMS TO KNOW THE CAUSE OF HER BLOCKAGE. CONSUMER REPORTED THAT SHE HAS BEEN USING BIOTENE MOUTH SPRAY, ORAL RINSE AND TOOTHPASTE FOR OVER A YEAR. SHE STATED THAT A LITTLE OVER TWO MONTHS AGO THAT THE PRODUCTS STARTED BURNING HER MOUTH. SHE STATED THAT SHE HAS BURNS, SORES AND BLISTERS ON HER LIPS, INSIDE HER MOUTH AND ON HER GUMS. SHE REPORTED THAT SHE ALSO HAD THESE BURNS, SORES AND BLISTERS ABOUT A YEAR AGO AND HAD A BIOPSY DONE ON THEM. SHE STATED THAT SHE IS NOT CERTAIN WHAT IS CAUSING THE BURNS, SORES AND BLISTERS. CONSUMER REPORTED THAT HER NAUSEA, CHEST PAIN AND BLOCKAGE IN HER ARTERY HAS RESOLVED. SHE IS STILL CURRENTLY EXPERIENCING THE BURNS, SORES AND BLISTERS ON HER LIPS, INSIDE HER MOUTH AND ON HER GUMS. SHE IS STILL CURRENTLY USING THE BIOTENE ORAL RINSE AND THE NEW FORMULATION OF THE BIOTENE ORIGINAL TOOTHPASTE. SHE STATED THAT SHE STOPPED USING THE BIOTENE MOUTH SPRAY BECAUSE IT WAS RECALLED. CONSUMER HAS USED BOTH THE NEW AND OLD FORMULATIONS OF BOTH THE BIOTENE MOUTH SPRAY AND THE TOOTHPASTE. CONSUMER REPORTED TRYING BIOTENE GUM IN THE PAST AND IT DID NOT DO A THING FOR HER DRY MOUTH. MULTIPLE LOT CODES IN CASE. THE FIRST MFR'S REPORT NUMBER FOR THIS CASE IS 1718912-2013-00026. BIOTENE MOISTURIZING MOUTH SPRAY IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, THE PRODUCT WILL NOT BE RETURNED FOR QA TESTING. THE SECOND MFR'S REPORT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, THE PRODUCT WILL NOT BE RETURNED FOR QUALITY QA TESTING. THE THIRD MFR'S REPORT NUMBER FOR THIS CASE IS 1718912-2013-00028. BIOTENE MOISTURIZING MOUTH SPRAY IS MANUFACTURED IN SOUTH JORDAN, UT. AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. A1051805A.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PASSED OUT IN A (B)(6) FEMALE PT WHO RECEIVED ORAL MOISTURIZERS (BIOTENE MOISTURIZING MOUTH SPRAY 2013 FORMULATION) SPRAY FOR PRODUCT USED FOR UNK INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED BIOTENE DRY MOUTH ORAL RINSE. BIOTENE ORIGINAL TOOTHPASTE (1013 FORMULATION), BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE TOOTHPASTE, AND BIOTENE GUM. CONCURRENT MEDICATIONS INCLUDED OXYCODONE HYDROCHLORIDE (OXY CONTIN), OXYCODONE, INDOMETHACIN (INDOCIN), BENAZEPRIL, ASPIRIN, POTASSIUM SALT (POTASSIUM), VITAMIN D, MAGNESIUM SALT (MAGNESIUM), EZETIMIBE (ZETIA), CLOPIDOGREL BISULPHATE (PLAVIX), AND FRUSEMIDE (FUROSEMIDE). IN 2012, THE PT STARTED ORAL MOISTURIZERS (UNK) AT UNK DOSING. AT AN UNK TIME AFTER STARTING ORAL MOISTURIZERS, THE PT EXPERIENCED PASSED OUT, NAUSEA, CHEST PAIN, PERIPHERAL ARTERY OCCLUSION, FEMORAL BYPASS, BURNING MOUTH, BURNED LIP, SORE ON LIPS, LIP BLISTER, MOUTH SORES, BLISTERING OF MOUTH, GUM SORES, GINGIVAL BLISTER, AND LACK OF EFFECT. THE PT WAS HOSPITALIZED. TREATMENT WITH ORAL MOISTURIZERS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633030 BIOTENE DRY MOUTH ORAL RINSE ORAL MOISTUREZERS LFD GLAXOSMITHKLINE NA 2A24C1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization