BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (ORIGINAL AND FREE)

    MDR report key: 1880499 · Received October 14, 2010

    Report

    Report Number
    9681138-2010-00352
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    October 14, 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

    (B)(4). ADD'L LOT#: V10185.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A CURRENTLY (B)(6) MALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) AND SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE 20 TO 25 YEARS PRIOR TO REPORTING, THE PT STARTED THE FORMULATIONS OF SUPER POLIGRIP. IN (B)(6) 2000, AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED ANEMIA AND LOW IRON LEVELS. THE PT EXPERIENCED DEVICE MISUSE WITH BOTH SUPER POLIGRIP ORIGINAL AND SUPER POLIGRIP FREE BECAUSE HE WOULD BE REAPPLYING THE PRODUCT MORE THAN ONCE PER DAY AND AGAIN WHEN HE WOULD EAT. THE PT LODGED A PRODUCT COMPLAINT WITH SUPER POLIGRIP FREE OF IT NOT HOLDING HIS DENTURES IN LONGER THAN 4 TO 5 HOURS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED USING SUPER POLIGRIP FOR THE PAST 20 TO 25 YEARS AND IS NOT SURE IF USING THE PRODUCT IS THE CAUSE OF HIS DIAGNOSIS OF ANEMIA ABOUT 10 YEARS AGO IN (B)(6). CONSUMER REPORTED HE GETS HIS BLOOD WORK CHECKED EVERY 6 MONTHS FOR ANEMIA AND THE HIGHEST IT GOT TO WAS 10.8 AND THE LOWEST BEING 9.4. HE CURRENTLY HAD IT CHECKED IN (B)(6) 2010 AND IT WAS AT 9.6. CONSUMER REPORTED EVENT OF LOW IRON COULD ALSO BE FROM USING SUPER POLIGRIP. SUPER POLIGRIP IS MFG IN (B)(4). WHILE THE LOT NUMBERS FOR THESE PRODUCTS IS AVAILABLE, IT IS UNK WHETHER THE PRODUCTS WILL BE RETURNED FOR QA TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (ORIGINAL AND FREE) DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE R10145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other