BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2163558 · Received June 9, 2011

    Report

    Report Number
    9681138-2011-00139
    Event Type
    Other
    Date Received
    June 9, 2011
    Date of Event
    January 1, 2009
    Report Date
    June 8, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A PATIENT WHO USED POLIGRIP (FORMULATION UNKNOWN) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT USED POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIGRIP, THE PATIENT EXPERIENCED A NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 05/31/2011 VIA FACT SHEETS SUBMITTED BY THE PATIENT AND/OR THE PATIENT'S ATTORNEY. IN (B)(6) 2009, THE PATIENT REPORTED HAVING MUSCLE TIGHTNESS IN HIPS AND LEGS, THE NEED TO SWING LEGS TO GET MOVING DUE TO PAIN AND WEAKNESS, AND DIFFICULTY WALKING. IN (B)(6) 2009, THE PATIENT COMPLAINED OF SHARP LEFT HAND PAIN AND SHOOTING PAIN WHEN PICKING THINGS UP. IN (B)(6) 2010, THE PATIENT HAD MUSCLE WEAKNESS AND PAIN IN ARMS, DIFFICULTY LIFTING THINGS IN RIGHT ARM, AND PAIN IN LEFT ARM THAT MADE THE PATIENT UNABLE TO LIFT IT OVER HIS HEAD. IN (B)(6) 2010, THE PATIENT HAD RIGHT ELBOW PAIN. ON (B)(6) 2010, THE PATIENT WAS SEEN FOR NEUROPATHY AND RELATED SYMPTOMS. IN (B)(6) 2010, THE PATIENT HAD MUSCLE TINGLING, PAIN, CRAMPING, AND UNCONTROLLED TWITCHING. THE PATIENT FIRST USED UPPER PARTIAL DENTURES IN (B)(6) 1998. SUPER POLIGRIP ORIGINAL WAS USED FROM (B)(6) 1998 UNTIL 2010, ONE TO TWO TIMES DAILY, LESS THAN ONE 2.4 OUNCE TUBE WEEKLY. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS AFTER FURTHER ASSESSMENT BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other