BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (ULTRA FRESH & EXTRA CARE)

    MDR report key: 2011793 · Received February 21, 2011

    Report

    Report Number
    9681138-2011-00049
    Event Type
    Other
    Date Received
    February 21, 2011
    Report Date
    February 18, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP ULTRA FRESH IS KNOWN WHILE THE LOT NUMBER FOR SUPER POLIGRIP EXTRA CARE WITH POLISEAL IS UNKNOWN. IT IS NOT KNOWN WHETHER THE PRODUCTS WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4). ADDITIONAL LOT #: UNK.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A (B)(6) FEMALE PATIENT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP EXTRA CARE WITH POLISEAL ((B)(4)) FOR DENTURE ADHESION. ON AN UNKNOWN DATE, THE PATIENT STARTED THE FORMULATIONS OF SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING THE FORMULATIONS OF SUPER POLIGRIP, THE PATIENT EXPERIENCED ANEMIA, TINGLING OF LIP AND TINGLING GUM. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH THE FORMULATIONS OF SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE PATIENT DID NOT PROVIDE CONTACT INFORMATION. THEREFORE, THIS CASE IS LOST TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (ULTRA FRESH & EXTRA CARE) DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE R10344

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other