BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 3259901 · Received July 30, 2013

    Report

    Report Number
    1020379-2013-00008
    Event Type
    Other
    Date Received
    July 30, 2013
    Report Date
    July 29, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT OVERNIGHT TABLETS ARE MANUFACTURED 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 AND DESCRIBED THE OCCURRENCE OF URINARY TRACT INFECTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED TWO VARIANTS OR DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS AND POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED URINARY TRACT INFECTION. CONCURRENT MEDICAL CONDITIONS INCLUDED BIPOLAR, HYPOTHYROIDISM, KNEE ARTHRITIS AND LUPUS. CONCURRENT MEDICATIONS INCLUDED TYLENOL WITH CODEINE NO. 3 (TYLENOL WITH CODEINE #3), "AZO", HYDROCHLOROTHIAZIDE, CLONAZEPAM, SEMISODIUM VALPROATE (DEPAKOTE, THYROXINE SODIUM (LEVOTHYROXINE), INJECTABLE ARTHRITIS MEDICATION AND UNKNOWN INJECTION FOR LUPUS. ON AN UNKNOWN DATE(S), THE PATIENT STARTED THE FORMULATIONS OF DOUBLE SALT DENTURE CLEANSER. AT AN UNKNOWN TIME AFTER STARTING THE FORMULATIONS FOR DOUBLE SALT DENTURE CLEANSER, THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND BURNING ON URINATION. THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH CIPROFLOXACIN HYDROCHLORIDE (CIPRO). TREATMENT WITH DOUBLE SALT DENTURE CLEANSER WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. SAE REPORTED (B)(6) VIA PHONE: CONSUMER REPORTED THAT SHE HAS FREQUENT VISITS TO THE HOSPITAL FOR URINARY TRACT INFECTIONS. SHE STATED THAT APPROXIMATELY TWO YEARS AGO AFTER SHE HAD HER TEETH EXTRACTED SHE WAS ADMITTED INTO THE HOSPITAL FOR A URINARY TRACT INFECTION FOR THREE DAYS. SHE COULD NOT PROVIDE THE SPECIFIC DATES OR DETAILS ABOUT HER HOSPITAL ADMISSION. SHE REPORTED THAT SHE DID NOT TELL THE DOCTOR'S THAT SHE WAS USING POLIDENT WHILE SHE WAS IN THE HOSPITAL. SHE ALSO STATED THAT HER DOCTOR NOW IS NOT AWARE THAT SHE'S USING POLIDENT. SHE STATED THAT THE CAUSE OF HER FREQUENT URINARY TRACT INFECTIONS IS UNKNOWN. SHE STATED THAT SHE HAS SEEN A KIDNEY SPECIALIST AND WAS TOLD THAT HER KIDNEYS LOOK GOOD. CONSUMER REPORTED THAT WHEN SHE HAS A URINARY TRACT INFECTION SHE WAKES UP AT NIGHT AND HAS REALLY BAD BURNING WHILE URINATING. SHE STATED THAT SHE WAS STARTED ON CIPRO 500 MG TWICE A DAY YESTERDAY, (B)(6) 2013, TO TREAT HER CURRENT URINARY INFECTION. SHE REPORTED THAT SHE HAS APPOINTMENT WITH HER DOCTOR ON THE (B)(6) FOR A FOLLOW UP BUT DID NOT STATE THE MONTH OF HER FOLLOW UP APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354669 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization HYDROCHLOROTHIAZIDE| DEPAKOTE| UNK INJECTION| CLONAZEPAM| LEVOTHYROXINE| ARTHRITIS MEDICATION| TYLENOL WITH CODEINE #3