BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/POLIDENT

    MDR report key: 2011746 · Received March 4, 2011

    Report

    Report Number
    9681138-2011-00059
    Event Type
    Other
    Date Received
    March 4, 2011
    Report Date
    March 3, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    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 MALE PT WHO USED POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2005, DURING AN INITIAL EVALUATION WITH A CHIROPRACTOR, THE PT COMPLAINED OF NECK PAIN RADIATING INTO BOTH ARMS, ACHING IN UPPER RIGHT ARM, RIGHT AND LEFT HIP PAIN, AND LEGS FEELING TIRED. THIS HAD BEEN "OFF AND ON" FOR YEARS. ON (B)(6) 2009, THE PT REPORTED HAVING NUMBNESS IN HIS FINGERS AND TOES AT TIMES, AS WELL AS A HISTORY OF A BACK INJURY. THE PT HAD SEEN A CHIROPRACTOR FOR YEARS RELATED TO HIS BACK INJURY, WHICH STILL GAVE HIM PROBLEMS. ASSESSMENT INCLUDED RAYNAUD'S SYNDROME, CERVICAL AND LUMBAR SPONDYLOSIS, AND PERIPHERAL NEUROPATHY. THE PT HAD DEGENERATIVE CHANGES IN BOTH UPPER AND LOWER SPINE WITH C3 RETROLISTHESIS. ON (B)(6) 2010, THE PT REQUESTED BLOOD TESTS FOR ZINC AND COPPER LEVELS. THE PT HAD HIRED LAWYERS IN A NATIONAL CASE AGAINST POLIDENT (FORMULATION UNK) DENTURE CREAM WHO WERE REQUESTING THIS INFO. THE PT HAD SEVERE IDIOPATHIC POLYNEUROPATHY FOR MANY YEARS. THE CASE CLAIMED THAT POLIDENT INCREASED BLOOD LEVELS OF ZINC AND DEPLETED COPPER, CAUSING HEALTH PROBLEMS. ON (B)(6) 2010, THE PT'S ZINC LEVEL WAS 1.27 (NORMAL 0.66 TO 1.10 MCG/ML) AND COPPER LEVEL WAS 0.93 (NORMAL 0.75 TO 1.45 MCG/ML). THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS PER GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP/POLIDENT DENTURE ADHESIVE PRODUCTS KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other