BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL BALANCE GEL (2013 FORMULATION)

    MDR report key: 4440379 · Received January 20, 2015

    Report

    Report Number
    1718912-2015-00005
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    December 1, 2014
    Report Date
    January 15, 2015
    Manufacturer
    ULTRADENT PRODUCTS/ORA TECH LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GSK CASE NUMBER (B)(4) IS A DUPLICATE OF CASE (B)(4). ALL FUTURE CORRESPONDENCE WILL BE SUBMITTED TO CASE (B)(4).

    Description of Event or Problem · 1

    GALL BLADDER DISORDER [GALLBLADDER DISORDER]. PAIN IN SIDE [PAIN LOCALIZED]. BALL BLADDER REMOVED [CHOLECYSTECTOMY]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF GALLBLADDER DISORDER IN A (B)(6)-YEAR-OLD-MALE PT WHO RECEIVED ORAL MOISTURISERS (BIOTENE ORAL BALANCE GEL (2013 FORMULATION)) GEL (BATCH NUMBER W4B081, EXPIRY DATE 12/31/2015) FOR AN UNK INDICATION. CONCOMITANT PRODUCTS INCLUDED WARFARIN. IN 2014, THE PT STARTED BIOTENE ORAL BALANCE GEL (2013 FORMULATION). IN (B)(6) 2014, AN UNK TIME AFTER STARTING BIOTENE ORAL BALANCE GEL (2013 FORMULATION), THE PT EXPERIENCED GALLBLADDER DISORDER (SERIOUS CRITERIA HOSPITALIZATION) AND PAIN LOCALIZED (SERIOUS CRITERIA HOSPITALIZATION). ON (B)(6) 2014, THE PT EXPERIENCED CHOLECYSTECTOMY (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). BIOTENE ORAL BALANCE GEL (2013 FORMULATION) WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON (B)(6) 2014, THE OUTCOME OF THE GALLBLADDER DISORDER AND CHOLECYSTECTOMY WERE RECOVERED/RESOLVED. ON AN UNK DATE, THE OUTCOME OF THE PAIN LOCALIZED WAS RECOVERED/RESOLVED. IT WAS UNK IF THE REPORTER CONSIDERED THE GALLBLADDER DISORDER, PAIN LOCALIZED, AND CHOLECYSTECTOMY TO BE RELATED TO BIOTENE ORAL BALANCE GEL (2013 FORMULATION). ON (B)(6) 2015, THE CONSUMER REPORTED STARTING USE OF BIOTENE GELL APPROXIMATELY 4-5 MONTHS PRIOR TO REPORT DATE. CONSUMER USED A TOTAL OF THREE TUBES, STATING THAT HE USED ABOUT ONE TUBE PER MONTH. CONSUMER WENT TO ER ON (B)(6) 2014 AFTER EXPERIENCING THE ADVERSE EVENTS OF PAIN ON SIDE, TENDERNESS ON SIDE, AND SORENESS ON SIDE FOR APPROXIMATELY TWO WEEKS. CONSUMER REPORTED THAT X-RAYS SHOWED A GALLBLADDER DISORDER, FURTHER DESCRIBED AS DETERIORATION OF GALLBLADDER WITH BILE AROUND IT, AND THAT HE WAS ADMITTED. CONSUMER HAD HIS GALLBLADDER REMOVED ON (B)(6) 2014.

    Description of Event or Problem · 1

    BLOOD IN STOOL. DARK COLORED STOOLS. LIGHT HEADEDNESS [LIGHT HEADEDNESS]. FOLLOW UP INFORMATION WAS RECEIVED ON JULY 7, 2015. THE CONSUMER REPORTED THE OCCURRENCE OF BLOOD IN STOOL (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), STOOL DISCOLORED AND LIGHT HEADEDNESS. HE REPORTED THAT HIS DOCTOR TOLD HIM IT WAS PROBABLY DRIED BLOOD OR DIGESTED BLOOD IN HIS STOOL. HE RECEIVED SODIUM FLUORIDE (BIOTENE FRESH MINT TOOTHPASTE (SAVANNAH)) UNKNOWN (BATCH NUMBER (B)(4), EXPIRY DATE FEBRUARY 28, 2017) FOR AN UNKNOWN INDICATION, ORAL MOISTURIZERS (BIOTENE ORAL BALANCE GEL (SAVANNAH)) UNKNOWN (BATCH NUMBER (B)(4). , EXPIRY DATE MARCH 31, 2016) FOR AN UNKNOWN INDICATION, GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER (B)(4), EXPIRY DATE FEBRUARY 28, 2017) FOR AN UNKNOWN INDICATION AND ORAL MOISTURIZERS (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) UNKNOWN (BATCH NUMBER (B)(4), EXPIRY DATE JUNE 30, 2017) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE FRESH MINT TOOTHPASTE (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY, BIOTENE ORAL BALANCE GEL (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY, BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) AT AN UNKNOWN DOSE AND FREQUENCY AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE FRESH MINT TOOTHPASTE (SAVANNAH), BIOTENE ORAL BALANCE GEL (SAVANNAH), BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH), THE PATIENT EXPERIENCED BLOOD IN STOOL (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), STOOL DISCOLORED AND LIGHT HEADEDNESS. BIOTENE FRESH MINT TOOTHPASTE (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). BIOTENE ORAL BALANCE GEL (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE BLOOD IN STOOL, STOOL DISCOLORED AND LIGHT HEADEDNESS WERE NOT RECOVERED/NOT RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BLOOD IN STOOL, STOOL DISCOLORED AND LIGHT HEADEDNESS TO BE RELATED TO BIOTENE FRESH MINT TOOTHPASTE (SAVANNAH), BIOTENE ORAL BALANCE GEL (SAVANNAH), BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45148 BIOTENE ORAL BALANCE GEL (2013 FORMULATION) ORAL GEL LFD ULTRADENT PRODUCTS/ORA TECH LLC W4B081

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention