BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP EXTRA CARE WITH POLISEAL

    MDR report key: 1943614 · Received December 14, 2010

    Report

    Report Number
    9681138-2010-00410
    Event Type
    Other
    Date Received
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS 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 POSSIBLE ALLERGIC REACTION IN A (B)(6) MALE PT WHO RECEIVED SUPER POLIGRIP EXTRA CARE WITH POLISEAL ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP EXTRA CARE WITH POLISEAL GEL. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP EXTRA CARE WITH POLISEAL, THE PT EXPERIENCED POSSIBLE ALLERGIC REACTION CHARACTERIZED BY FACIAL RASH, FACIAL PRURITUS AND BEING UNABLE TO SLEEP. THE PT ALSO STATED THAT HE THINKS THAT HE HAS SKIN CANCER ON HIS FACE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP EXTRA CARE WITH POLISEAL WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THIS CONSUMER REPORTED A PRODUCT COMPLAINT OF SUPER POLIGRIP EXTRA CARE CONTAINING LITTLE PIECES OF PLASTIC INSIDE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP EXTRA CARE WITH POLISEAL DENTURE ADHESIVE GEL KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other