BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE CREAM

    MDR report key: 1880546 · Received October 18, 2010

    Report

    Report Number
    9681138-2010-00353
    Event Type
    Other
    Date Received
    October 18, 2010
    Report Date
    October 18, 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 NUMBNESS ON SIDE IN A (B)(6), FEMALE, PT, WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION (B)(4)) OVER A PERIOD OF 8 YRS FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED DONEPEZIL HYDROCHLORIDE (ARICEPT), CITALOPRAM, ALENDRONATE SODIUM (FOSAMAX), LISINOPRIL, CYANOCOBALAMIN (VITAMIN B 12), VITAMIN D, AND ASPIRIN (BABY ASPIRIN). PT REPORTED THAT SHE HAS A HISTORY OF BEGINNING ALZHEIMER'S AND IS NOT EXACT ON DATES. PT REPORTED THAT ABOUT (B)(6) 2010 SHE WENT TO THE HOSPITAL AND HAD A CT SCAN DONE. THE REASON FOR THE CT SCAN WAS NOT REPORTED. ON AN UNK DATE EIGHT YRS PRIOR TO REPORTING, THE PT STARTED SUPER POLIGRIP. UPON AWAKENING ON THE MORNING OF (B)(6) 2010, THE PT EXPERIENCED NUMBNESS ON HER LEFT SIDE, NUMBNESS IN SHOULDER, LOWER EXTREMITY NUMBNESS, NUMBNESS IN BUTTOCK, GENITAL NUMBNESS, LEG NUMBNESS, NUMBNESS OF UPPER PART OF HER SKIN AND TENDERNESS OF UNDERSIDE OF SKIN. THE PT ATTEMPTED TO GET HOLD OF HER DOCTOR AND WHEN SHE DID THE DOCTOR SENT HER TO THE HOSPITAL. THE PT BELIEVES THAT IT WAS (B)(6) 2010 THAT SHE WAS ADMITTED TO THE HOSPITAL. DIAGNOSTIC TESTING INCLUDED THREE DIFFERENT MAGNETIC RESONANCE IMAGING (MRI) SCANS COMPUTED TOMOGRAPHY (CT) SCAN, UNSPECIFIED BLOOD WORK DRAWN AND NERVE RESPONSE TEST. ALL OF THE RESULTS WERE NEGATIVE. WHILE HOSPITALIZED, THE PT DEVELOPED BACK TIGHTNESS AND WAS STARTED ON LYRICA. CUSTOMER WAS DISCHARGED TO HOME. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE PT LODGED A PRODUCT COMPLAINT OF SUPER POLIGRIP NOT HOLDING MORE THAN FOUR HOURS. SHE REPORTED THAT SHE GENERALLY ONLY WORE THE DENTURES WHEN SHE WENT OUT, ABOUT 4 HRS. IF SHE WAS GOING TO BE OUT LONGER THAN 4 HRS SHE WOULD NEED TO APPLY THE SUPER POLIGRIP IN A STRIP ALL THE WAY AROUND THE DENTURE AS OPPOSED TO THE WAY THE DIRECTIONS SHOWED (DEVICE MISUSE). THE PURPOSE OF THIS CONTACT WAS TO INQUIRE ABOUT THE POSSIBILITY OF CONSUMERS ADVERSE EVENTS AND THE CONNECTION TO HER USE OF SUPER POLIGRIP. AT THE TIME OF THE REPORT THE CONSUMER HAD STOPPED USE OF SUPER POLIGRIP BUT INTENDS TO USE THE NEW ZINC FREE FORMULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization ALENDRONATE SODIUM| CITALOPRAM| DONEPEZI HCL| LISINOPRIL| ASPIRIN| VITAMIN D| CYANOCOBALAMIN