BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 3002020 · Received March 11, 2013

    Report

    Report Number
    9681138-2013-00003
    Event Type
    Other
    Date Received
    March 11, 2013
    Report Date
    March 8, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00003. 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 PERIPHERAL NEUROPATHY IN A (B)(6) FEMALE PATIENT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATIONS INCLUDED CALCIUM SODIUM POLY (VINYL METHYL ETHER-MALEATE) (FIXODENT). ON AN UNKNOWN DATE, THE PATIENT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM. ON AN UNKNOWN DATE, THE PATIENT STARTED CALCIUM SODIUM POLY (VINYL METHYL ETHER-MALEATE). AT AN UNKNOWN TIME AFTER STARTING TRIPLE SALT DENTAL ADHESIVE CREAM AND CALCIUM SODIUM POLY (VINYL METHYL ETHER-MALEATE), THE PATIENT EXPERIENCED PERIPHERAL NEUROPATHY, METAL POISONING AND DEVICE MISUSE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH TRIPLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CALLER REPORTED DEVICE MISUSE OF USING MORE THAN RECOMMENDED AMOUNTS OF UNKNOWN SUPER POLIGRIP CREAM ADHESIVES. CALLER REPORTED ZINC POISONING FURTHER DESCRIBED AS I AM BEING TESTED FOR ZINC POISONING. IT IS NOT KNOWN IF THE EVENT OF ZINC POISONING CONTINUES. CALLER REPORTS PERIPHERAL NEUROPATHY CONTINUES. CALLER REPORTED CO-SUSPECT PRODUCT FIXODENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102005 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOO GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other