BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2011795 · Received February 21, 2011

    Report

    Report Number
    9681138-2011-00046
    Event Type
    Other
    Date Received
    February 21, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT AND DESCRIBED THE OCCURRENCE OF INJURY IN A MALE PATIENT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING SUPER POLIGRIP. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. MEDICAL RECORDS RECEIVED 14 MARCH 2011: ON (B)(6) 2006, THE PATIENT WAS SEEN FOR NEUROPATHIC PAIN CAUSING BURNING AND STINGING IN HIS THIGHS. HE ALSO HAD RHEUMATOID ARTHRITIS AND REQUIRED CHRONIC PAIN MANAGEMENT VIA AN INTRATHECAL PUMP. POLYNEUROPATHY WAS LISTED AS A DIAGNOSIS AT A VISIT ON (B)(6) 2006. ON (B)(6) 2007, THE PATIENT COMPLAINED OF ANKLE PAIN AND THE FRONT OF HIS THIGHS STINGING "LIKE NEEDLES." NEUROPATHIC PAIN WAS NOTED AT FOLLOW UP THROUGH (B)(6) 2009. ON (B)(6) 2009, THE PATIENT REPORTED RECENTLY SEEING AN ARTICLE CONCERNING COPPER AS A CAUSE OF NEUROPATHY AND QUESTIONED IF THIS COULD BE WORSENING HIS SYMPTOMS. COPPER WAS MEASURED AT 64 MCG/DL (NORMAL 70 TO 155) AT THAT TIME. HIS NEUROPATHIC PAIN WAS INCREASED BY FOLLOW UP ON (B)(6) 2010, AND ON (B)(6) 2010, HE QUESTIONED TESTING FOR ZINC ABNORMALITIES. THIS CASE WAS NOW CONSIDERED MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other