BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 6724900 · Received July 19, 2017

    Report

    Report Number
    1718912-2017-00021
    Event Type
    Injury
    Date Received
    July 19, 2017
    Report Date
    June 27, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), BIOTENE MOUTH SPRAY.

    Description of Event or Problem · 1

    I JUST CAME OUT OF THE HOSPITAL [HOSPITALIZATION], I HAVE CATARACTS IN ONE EYE [CATARACT], THE OTHER EYE IS SHIFTING NOW [EYE DISORDER], I AM NOT FEELING GOOD [FEELING ABNORMAL]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CATARACT IN A (B)(6) FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORAL BALANCE GEL (AROMA)) GEL (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH AND SODIUM FLUORIDE (BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH)) TOOTHPASTE (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DENTAL CLEANING. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH), BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH), THE PATIENT EXPERIENCED CATARACT, EYE DISORDER AND PRODUCT COMPLAINT. BIOTENE MOUTH SPRAY (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). BIOTENE ORAL BALANCE GEL (AROMA) WAS CONTINUED WITH NO CHANGE. BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH) WAS CONTINUED WITH NO CHANGE. ON AN UNKNOWN DATE, THE OUTCOME OF THE CATARACT AND EYE DISORDER WERE NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CATARACT AND EYE DISORDER TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH), BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH). ADDITIONAL DETAILS, THE ADVERSE EVENT INFORMATION WAS RECEIVED ON 27 JUNE 2017. CONSUMER REPORTED THAT, "THE PRODUCT IS BIOTENE ORAL BALANCE GEL 1.5 OZ (AROMA). A 1.5 OZ. TUBE ONLY LASTED FOR TWO DAYS. IT USUALLY LASTS FOR TWO WEEKS. I USE THE PRODUCT TWO TO FOUR TIMES PER DAY. I LOVE THIS. THE PRODUCT PRACTICALLY SAVED MY LIFE. I HAVE USED THE PRODUCT FOR MANY, MANY YEARS. IT HELPS ME. IT GIVES ME MOISTURE, AND I CAN TALK AND SWALLOW. THERE IS NOTHING ELSE LIKE IT. I ALSO USE THE TOOTHPASTE. I USED TO USE THE SPRAY. I HAVE CATARACTS IN ONE EYE. THE OTHER EYE IS SHIFTING NOW. I WILL BE SEEING THE DOCTOR FOR THAT." FOLLOW UP INFORMATION WAS RECEIVED ON 13 JULY 2017. CONSUMER USED BIOTENE ORAL BALANCE GEL 1.5 OZ (AROMA) AND BIOTENE TOOTHPASTE SAVANNAH. SHE STATED THAT SHE USED TO USE THE BIOTENE MOUTH SPRAY. CONSUMER STATED, "I AM NOT FEELING GOOD. I JUST CAME OUT OF THE HOSPITAL." CONSUMER WAS (B)(6). SHE STATED THAT SHE USED BIOTENE ORAL BALANCE GEL 1.5 OZ (AROMA) TWO TO FOUR TIMES PER DAY. THE HOSPITALIZATION AND FEELING ABNORMAL EVENT WERE ADDED TO CASE. EVENT OUTCOME FOR HOSPITALIZATION AND FEELING ABNORMAL WAS UNKNOWN. THE CAUSALITY FOR HOSPITALIZATION AND FEELING ABNORMAL WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED HOSPITALIZATION AND FEELING ABNORMAL TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH), BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE TOOTHPASTE VARIANT NOT SPECIFIED (SAVANNAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504488 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O