BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTU CREME DENTURE TOOTHPASTE

    MDR report key: 1318382 · Received February 18, 2009

    Report

    Report Number
    2210777-2009-00001
    Event Type
    Other
    Date Received
    February 18, 2009
    Report Date
    February 18, 2009
    Manufacturer
    GLAXOSMITHKLINE RTP, NC
    Product Code
    EFT
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (B)(4) (POLIDENT DENTU CRÈME TOOTHPASTE) FOR DENTURE CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED DOUBLE SALT DENTURE CLEANSER (B)(4) (DENTAL). AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER (B)(4), THE PATENT EXPERIENCED NEUROPATHY AND TINGLING OF HANDS AND FEET. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTURE CLEANSER (B)(4) WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. (B)(4). POLIDENT DENTU CRÈME DENTURE TOOTHPASTE IS MANUFACTURED IN (B)(4) IN THE UNITED STATES OF AMERICA. THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DENTU CREME DENTURE TOOTHPASTE DENTURE TOOTHPASTE EFT GLAXOSMITHKLINE RTP, NC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other