BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (FREE AND ORIGINAL)

    MDR report key: 1912889 · Received November 11, 2010

    Report

    Report Number
    9681138-2010-00384
    Event Type
    Other
    Date Received
    November 11, 2010
    Report Date
    November 9, 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 IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP ORIGINAL IS UNK WHILE THE LOT NUMBER OF SUPER POLIGRIP IS KNOWN. 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 DIZZINESS IN A MALE PT WHO REC'D SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED ZINC SALT (ZINC SUPPLEMENT). ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ORIGINAL. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP ORIGINAL, THE PT EXPERIENCED DIZZINESS AND VERTIGO. TREATMENT WITH SUPER POLIGRIP ORIGINAL WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT OF VERTIGO WAS RESOLVED WHILE THE EVENT OF DIZZINESS WAS UNRESOLVED. CONSUMER REPORTED THAT HE IS USING SUPER POLIGRIP ORIGINAL AND IS EXPERIENCING VERTIGO AND DIZZINESS. CONSUMER ALSO STATED THAT HE EXPERIENCED THESE SAME EVENTS ABOUT 1 YR AGO ON A SEPARATE TUBE OF SUPER POLIGRIP. F/U WAS REC'D (B)(6) 2010 WHICH UPGRADED THE CASE TO SERIOUS: CONSUMER CALLED BACK AND REPORTED VERTIGO WHILE USING SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM ((B)(4)), LOT NUMBER X10242 AND DEVICE MISUSE OF USING SUPER POLIGRIP FREE TWO TO THREE TIMES A DAY. HE ALSO REPORTED BEING DIAGNOSED WITH NEUROPATHY ONE OR TWO YRS AGO. THIS CASE IS CONSIDERED MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING THE EVENT OF VERTIGO WAS RESOLVED AND THE EVENT OF NEUROPATHY WAS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FREE AND ORIGINAL) DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE X10242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other