BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP EXTRA CARE WITH POLISEAL

    MDR report key: 1530955 · Received October 27, 2009

    Report

    Report Number
    9681138-2009-00163
    Event Type
    Other
    Date Received
    October 27, 2009
    Report Date
    October 23, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2009-00163. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NONSPECIFIC REACTION IN A (B)(6) MALE PT WHO RECEIVED SUPER POLIGRIP EXTRA CARE WITH POLISEAL (FORMULATION (B)(4)) GEL FOR ONE MONTH FOR ADHESION OF HIS NEW PARTIAL DENTURE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED VALSARTAN (DIOVAN). THE PT USED SUPER POLIGRIP EXTRA CARE ONCE DAILY BEGINNING APPROX ONE MONTH AGO TO HOLD HIS NEW PARTIAL DENTURES. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED NERVE PAIN, MUSCLE ACHE, PAIN IN BACK OF LEFT SHOULDER THAT INVOLVED THE SHOULDER JOINT AND HIS LEFT BICEPS. THE PT STATED THAT HIS BLOOD PRESSURE WAS ELEVATED ("REALLY SPIKED"), HIS CHOLESTEROL WAS ELEVATED AND HE HAD DOUBLE VISION IN HIS LEFT EYE. HE ALSO HAD A NONSPECIFIC REACTION, MUSCLE PROBLEMS AND NERVE PROBLEMS. THE PT SAW AN OPHTHALMOLOGIST WHO SENT HIM TO THE EMERGENCY ROOM. THE PT WAS ADMITTED TO THE HOSP ON (B)(6) 2009, DUE TO POSSIBLE STROKE OR POSSIBLE ANEURYSM. HE HAD TESTS INCLUDING 2 MAGNETIC RESONANCE IMAGING SCANS OF BRAIN (WITH AND WITHOUT CONTRAST DYE), AN ECHOCARDIOGRAM, CHEST X-RAY AND UNSPECIFIED BLOOD TESTS. HE SAW A PHYSICAL THERAPIST AND AN OCCUPATIONAL THERAPIST. HE REPORTED EVERYTHING WAS NEGATIVE. THE PT WAS TREATED WITH CLOPIDOGREL BISULPHATE (PLAVIX), NIFEDIAC AND SIMVASTATIN. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. HE REPORTED ONE DOCTOR TOLD HIM HIS REACTION COULD BE DUE TO WEAK VIRUS AND HIS PRIMARY CARE PHYSICIAN TOLD HIM IT WAS DEFINITELY A VIRUS. HE WAS DISCHARGED TO HOME ON (B)(6) 2009, ON NEW MEDICATIONS AND HIS DIOVAN WAS INCREASED. HE ALSO SAW A NEUROLOGIST. HE REPORTED HE NOW HAS INTERMITTENT ARM AND NECK PAIN, HIS SHOULDER STILL HURTS, THE DOUBLE VISION IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP EXTRA CARE WITH POLISEAL DENTURE ADHESIVE GEL KOL GLAXOSMITHKLINE R09064

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization VALSARTAN