BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 1981194 · Received January 25, 2011

    Report

    Report Number
    9681138-2011-00022
    Event Type
    Other
    Date Received
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 15 (NORMAL 70 TO 155 MCG/DL) AND ZINC LEVEL WAS 166 (NORMAL 70 TO 150 MCG/SL). (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A MALE PATIENT WHO USED SUPER 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 BEGAN USING SUPER POLIGRIP. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED UNSPECIFIED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2005, THE PATIENT COMPLAINED OF BILATERAL FEET/LEG PAIN. DIAGNOSES INCLUDED DIABETIC NEUROPATHY OF BILATERAL LOWER EXTREMITIES. ON (B)(6) 2005, THE PATIENT COMPLAINED OF BILATERAL HANDS WITH NUMBNESS, EDEMA, AND PAIN DAILY, AS WELL AS LOWER BACK PAIN. DIAGNOSES INCLUDED CARPAL TUNNEL SYMPTOMS AND LOWER BACK PAIN. ON (B)(6) 2005, THE PATIENT FELL AT WORK AND LANDED ON HIS RIGHT SIDE. THE PATIENT COMPLAINED OF RIGHT SHOULDER, HIP, NECK, AND WRIST PAIN. DIAGNOSES INCLUDED MYALGIAS AND CONTUSIONS TO BACK, RIGHT SHOULDER, RIGHT HIP, AND WRIST. ON (B)(6) 2006, THE PATIENT COMPLAINED OF PARESTHESIAS OF FINGERS. ON (B)(6) 2006, THE PATIENT COMPLAINED OF RIGHT FOOT PAIN AND BACK PAIN. DIAGNOSES INCLUDED POSSIBLE PERIPHERAL NEUROPATHY (PARTS ILLEGIBLE DUE TO HANDWRITTEN NOTES). FROM (B)(6) 2006 UNTIL (B)(6) 2009, THE PATIENT CONTINUED TO COMPLAIN OF NUMBNESS TO HIS FINGERS AND HANDS AND NECK/BACK/LEFT KNEE PAIN. DIAGNOSES INCLUDED CARPAL TUNNEL, CARPAL TUNNEL RELEASE, PERIPHERAL NEUROPATHY, SCOLIOSIS, ATHEROSCLEROTIC VASCULAR CALCIFICATIONS, AND LOWER BACK PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other