BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (EXTRA CARE AND ORIGINAL)

    MDR report key: 1943563 · Received December 7, 2010

    Report

    Report Number
    9681138-2010-00407
    Event Type
    Other
    Date Received
    December 7, 2010
    Report Date
    December 3, 2010
    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 EXTRA CARE WITH POLISEAL AND SUPER POLIGRIP ORIGINAL ARE MANUFACTURED IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP EXTRA CARE WITH POLISEAL IS AVAILABLE (LOT NUMBER X08474B) WHILE THE LOT NUMBER FOR SUPER POLIGRIP DENTURE CREAM IS UNK. IT IS UNK WHETHER THE PRODUCTS WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF INABILITY TO SPEAK IN A (B)(6) FEMALE PT WHO RECEIVED SUPER POLIGRIP EXTRA CARE WITH POLISEAL ((B)(4)) CREAM FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)). ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP EXTRA CARE WITH POLISEAL (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP EXTRA CARE WITH POLISEAL, THE PT EXPERIENCED INABILITY TO SPEAK, JAW PAIN, FACIAL PAIN, JAW LOCKED UP AND MOUTH FELT GLUED. THE PT REPORTED THAT THE PRODUCT ONLY HELD FOR A FEW SECONDS. SHE STATED THAT IT GLUES UP HER MOUTH, OOZES AND WAS DIFFICULT TO REMOVE. A PRODUCT COMPLAINT WAS LODGED WITH THIS REPORT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP EXTRA CARE WITH POLISEAL WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (EXTRA CARE AND ORIGINAL) DENTURE ADHESIVES KOL GLAXOSMITHKLINE X08474B

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O