BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 3077740 · Received April 23, 2013

    Report

    Report Number
    1718912-2013-00005
    Event Type
    Other
    Date Received
    April 23, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOTENE IS MANUFACTURED IN (B)(4) IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR LOT NUMBERS FOR THIS PRODUCT ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF EYE PAIN IN A FEMALE PT WHO RECEIVED GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME (BIOTENE DRY MOUTH ORAL RINSE) FOR TWO WEEKS FOR DRY MOUTH. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT CONDITIONS INCLUDE DRY MOUTH, DECREASED VISION IN LEFT EYE AND LIVING IN A NURSING HOME. ON AN UNKNOWN DATE, THE PT STARTED GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME THREE TIMES DAILY. AT AN UNKNOWN TIME AFTER STARTING GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME, THE PT EXPERIENCED EYE PAIN, EYE DRYNESS, EYE DISORDER, BLURRED VISION, ABNORMAL SENSATION IN EYE, OCULAR DISCOMFORT, SPEECH DISORDER, UNABLE TO THINK STRAIGHT, HAND TREMOR, NERVOUSNESS AND LACK OF EFFICACY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSOZYME WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED MULTIPLE LOT CODES FROM TWO BOTTLES OF BIOTENE DRY MOUTH RINSE THAT WAS POURED FROM A LARGER SIZE BOTTLE INTO A SMALLER SIZE BOTTLE. LOT NUMBERS WERE NOT AVAILABLE AS THE BIOTENE DRY MOUTH ORAL RINSE HAD BEEN DECANTED INTO ANOTHER BOTTLE. CONSUMER DIDN'T KNOW IF THERE WAS SOME BIOTENE DRY MOUTH ORAL RINSE LEFT IN THE SMALLER BOTTLE AT THE TIME THE BIGGER BOTTLE WAS POURED INTO IT. CONSUMER REPORTED THAT SHE WAS BORN IN 1917 BUT SHE COULDN'T GIVE HER EXACT AGE. DURING TIME OF CALL SHE SAID SHE WAS (B)(6) BUT SHE CONFIRMED MANY TIMES THAT SHE WAS BORN IN 1917. CONSUMER REPORTED THAT SHE HAS DRY MOUTH SO SHE HAS BEEN USING BIOTENE DRY MOUTH ORAL RINSE THREE TIMES A DAY FOR A COUPLE OF WEEKS NOW AND IT DOES NOT HELP MUCH FOR HER DRY MOUTH. CONSUMER REPORTED THAT SHE WOKE UP TODAY AND HAD EYE PAIN AND EYE DRYNESS SO SHE TOOK BIOTENE. SUBSEQUENTLY, HER EYE WAS BOTHERING HER, FURTHER DESCRIBED THAT HER EYE WAS BOTHERING HER BUT NOT AS BAD DURING TIME OF REPORT. CONSUMER REPORTED THAT SHE HAD AN ATTACK OF HER DRY MOUTH TODAY. AFTER USING BIOTENE, SHE EXPERIENCED AN EYE PROBLEM THAT LEFT HER VERY NERVOUS AND SHE CANNOT TALK STRAIGHT AND SHE CANNOT THINK STRAIGHT. CONSUMER REPORTED THAT HER HAND IS SHAKING AND SHE DOESN'T KNOW IF THIS IS FROM THE ATTACK SHE HAD TODAY WITH HER EYE PROBLEM. CONSUMER REPORTED THAT HER VISION IS NOT CLEAR EVEN THOUGH SHE HAS PRE-EXISTING CONDITION OF DECREASED VISION IN HER LEFT EYE. THE CONSUMER DOES NOT KNOW IF THIS OR ANY OF THE EXPERIENCES ARE FROM THE BIOTENE DRY MOUTH ORAL RINSE. CONSUMER REPORTED THE EXPERIENCE OF EYE PAIN HAS RESOLVED. CONSUMER REPORTED THE EXPERIENCES OF EYE PROBLEM, SENSITIVE EYES, VISION NOT CLEAR, EYE FEELS STRANGE, HER EYE BOTHERING HER BUT NOT AS BAD AS IT HAS BEEN, EYE FEELS UNCOMFORTABLE, DIFFICULTY SPEAKING, DIFFICULTY THINKING, HAND SHAKING AND NERVOUS ARE ALL ONGOING. IT IS UNKNOWN IF CONSUMER IS STILL EXPERIENCING EYE DRYNESS. EVEN THOUGH CONSUMER HAS HAD A LOSS OF VISION IN HER EYE, SHE STILL SAID SHE DID NOT KNOW IF UNCLEAR VISION TODAY IS FORM BIOTENE. CONSUMER IS IN A NURSING HOME AND ASKED A NURSE AND WAS TOLD NOTHING WAS WRONG WITH HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173319 BIOTENE DRY MOUTH ORAL RINSE GLUCOSE OXIDASE + LACTOPEROXIDASE + LFD ULTRADENT PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other