BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1943561 · Received December 6, 2010

    Report

    Report Number
    9681138-2010-00405
    Event Type
    Other
    Date Received
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 VIA A TOLLING AGREEMENT AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A MALE PT WHO RECEIVED POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED POLIGRIP (DENTAL). AT AN UNK TIME AFTER STARTING 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) 2010, VIA MEDICAL RECORDS. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS. ON (B)(6) 2010, THE PT WAS SEEN IN CONSULTATION FOR COMPLAINTS OF LOW BACK, BILATERAL BUTTOCK, AND LOWER EXTREMITY PAIN. THE PT HAD A CHRONIC HISTORY OF DEGENERATIVE DISK DISEASE OF THE LUMBOSACRAL SPINE, WHICH HAD WORSENED SINCE A MOTOR VEHICLE ACCIDENT IN (B)(6) 2009. THE PT NOW COMPLAINED OF STEADY LOW BACK PAIN THAT RADIATED TO THE BILATERAL BUTTOCKS AND DOWN THE BILATERAL LOWER EXTREMITIES. THE PT HAD A HISTORY OF LONGSTANDING LOWER EXTREMITY NEUROPATHY SECONDARY TO A METABOLIC DISORDER, ZINC TOXICITY WITH SECONDARY NEUROPATHIC PAIN, ANEMIA, DEPRESSION, AND DEGENERATIVE DISK DISEASE OF THE LUMBOSACRAL SPINE. PAST SURGICAL HISTORY INCLUDED RIGHT AND LEFT ROTATOR CUFF REPAIRS. MEDICATIONS INCLUDED COPPER SUPPLEMENTATION. MAGNETIC RESONANCE IMAGING (MRI) OF THE LUMBOSACRAL SPINE ON (B)(6) 2010, REVEALED A BULGING DISK AT L1 THROUGH S1 WITH MILD BILATERAL NEUROFORAMINAL STENOSIS FROM L2 THROUGH L5 AND MODERATE STENOSIS AT L5 THROUGH S1. ALL LEVELS ALSO SHOWED BILATERAL FACET JOINT OSTEOARTHRITIS. IMPRESSION ALSO INCLUDED BILATERAL LUMBAR RADICULOPATHY. THE PT HAD A HISTORY OF SIGNIFICANT RELIEF WITH EPIDURAL STEROID INJECTIONS. THE PT RECEIVED HIS FIRST OUT OF A SERIES OF THREE EPIDURAL STEROID INJECTIONS THAT DAY. THE OTHER INJECTIONS WERE GIVEN ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other