BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 2093599 · Received April 15, 2011

    Report

    Report Number
    9681138-2011-00087
    Event Type
    Other
    Date Received
    April 15, 2011
    Report Date
    April 13, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MFG 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 DAMAGE IN A FEMALE PT WHO USED POLIGRIP (FORMULATION UNKNOWN) 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 DAMAGE AND INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2005, ELECTROMYOGRAPHY (EMG) AND NERVE CONDUCTION STUDIES (NCS) WERE NORMAL. ON (B)(6) 2005, A BONE DENSITY SCAN SHOWED OSTEOPOROSIS (DIAGNOSED ORIGINALLY IN 2001) OF THE LUMBAR SPINE AND OSTEOPENIA OF THE LEFT HIP. ON (B)(6) 2007, IT WAS NOTED THAT THE PT HAD A FALL IN 200 THAT RESULTED IN A BULGING DISC AND SOME DEGENERATIVE DISC DISEASE. ON (B)(6) 2008, ASSESSMENT INCLUDED RIGHT SHOULDER PAIN/ROTATOR CUFF TENDINITIS WITH IMPINGEMENT. ONSET OF RIGHT SHOULDER SYMPTOMS BEGAN ON (B)(6) 2008. ON (B)(6) 2010, THE PT COMPLAINED OF A NUMBNESS AND BURNING SENSATION OF BOTH OF HER FEET. SHE HAD CONTINUED SHOULDER PAIN, BUT NOW IT SEEMED TO BE MORE LEFT THAN RIGHT. ON (B)(6) 2010, THE PT HAD EPIDURAL STEROID INJECTION FOR CERVICAL SPINAL STENOSIS. IN THE LAST (B)(6) MONTHS (SINCE 2009), THE PT HAS HAD AN ONSET OF A PROGRESSIVE INTENSIFYING ACHING DISCOMFORT ORIGINALLY IN THE LEFT POSTERIOR LATERAL SHOULDER, EXTENDING DISTALLY ALONG THE LEFT UPPER EXTREMITY INTO THE FIRST AND SECOND FINGER AND THUMB OF THE LEFT HAND. ON (B)(6) 2010, THE PT HAD REPEAT C5/6 EPIDURAL STEROID INJECTION FOR CERVICAL STENOSIS. SHE HAD VERY LITTLE, IF ANY RELIEF. THE PT HAD A VARIETY OF LEFT UPPER EXTREMITY PAIN AND PARESTHETIC RADICULAR-TYPE COMPLEX AND HAD ON MAGNETIC RESONANCE IMAGINGS (MRI), MULTIPLE LEVELS OF FORAMINAL STENOSIS, NARROWING, AND DEGENERATIVE CHANGES. ON (B)(6) 2010, THE PT HAD A NEUROSURGICAL CONSULT FOR NECK PAIN INTO THE LEFT SHOULDER, BICEPS, AND LATERAL FOREARM. THE PT HAD NUMBNESS AND TINGLING IN HER LEFT THUMB, SECOND, AND THIRD FINGERS. SYMPTOMS HAD BEEN PRESENT OVER THE LAST (B)(6) MONTHS WITHOUT INITIAL INJURY AND GRADUALLY HAVE GOTTEN WORSE. SHE FELT LIKE SHE WAS LOSING SOME STRENGTH IN HER LEFT HAND. A PREVIOUS MRI OF THE CERVICAL SPINE SHOWED MILD DEGENERATIVE CHANGES WITH FACET ARTHROPATHY THROUGHOUT THE CERVICAL SPINE, BUT NO SIGNIFICANT CANAL AND FORAMINAL STENOSIS. ON (B)(6) 2010, IT WAS REPORTED THE PT HAD RIGHT ROTATOR CUFF SURGERY IN APPROXIMATELY 2008. ASSESSMENT INCLUDED LEFT ROTATOR CUFF TENDINITIS AND LEFT CARPAL TUNNEL SYNDROME. ON (B)(6) 2010, THE PT HAD LEFT SHOULDER ARTHROSCOPY WITH DEBRIDEMENT OF GLENOHUMERAL ARTHRITIS, SUBACROMIAL DECOMPRESSION, AND DISTAL CLAVICLE RESECTION. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2011, THE PT COMPLAINED OF PROGRESSIVE DIFFICULTY WITH WALKING, BALANCE, COORDINATION, CRAMPS, AND SHARP PAINS IN THE RIGHT LEG. HER PROBLEMS WITH BALANCE HAD BEEN CHRONIC, AT LEAST GREATER THAN 10 TO 15 YEARS NOW, BUT SLOWLY PROGRESSIVE. IT WAS WORSENING OVER TIME. THE PT ALSO HAD NUMBNESS, TINGLING AND SOMETIMES BURNING OF THE BILATERAL LEGS AND HANDS. IMPRESSION INCLUDED A PERIPHERAL CAUSE SUCH AS NEUROPATHY, CAUSING A SENSORY TYPE ATAXIA, BUT THIS APPEARED TO BE LESS LIKELY OF A SLOWLY PROGRESSIVE ATAXIA, INCLUDING MOVEMENT DISORDER.

    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