BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT

    MDR report key: 2434686 · Received January 26, 2012

    Report

    Report Number
    1020379-2012-00001
    Event Type
    Other
    Date Received
    January 26, 2012
    Report Date
    January 25, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 1020379-2012-00001. POLIDENT TABLETS ARE MANUFACTURED IN (B)(4) IN THE UNITED STATES, 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 VIA A TELEVISION PRODUCER AND DESCRIBED THE OCCURRENCE OF ALLERGIC REACTION IN A (B)(6) FEMALE PT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER MFC50075 (POLIDENT) FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. IN LATE (B)(6) 2011, THE PT STARTED DOUBLE SALT DENTURE CLEANSER MFC50075. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER MFC50075, DESCRIBED AS AFTER JUST A FEW MONTHS OF USE, THE PT EXPERIENCED DIZZINESS, WEIGHT LOSS OF (B)(6), NASAL SORES, MOUTH SORES AND SICKNESS. THE PT PRESENTED TO THE EMERGENCY ROOM ON FIVE OCCASIONS AND WAS HOSPITALIZED TWICE. THE PT SUBSEQUENTLY READ THE INGREDIENTS ON THE POLIDENT BOX AND CAME TO THE CONCLUSION THAT SHE WAS ALLERGIC TO THE PERSULFATES IN POLIDENT. AT THE TIME OR REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 1020379-2012-00001. POLIDENT TABLETS ARE MANUFACTURED IN (B)(4) IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DOUBLE SALT DENTURE CLEANSER MFC50075 KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization