BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP POWDER AND DENTU GRIP POWDER

    MDR report key: 1912827 · Received November 5, 2010

    Report

    Report Number
    9681138-2010-00377
    Event Type
    Other
    Date Received
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND DENTU GRIP WAS MANUFACTURED IN (B)(4) AND WAS DISCONTINUED IN 2004. NEITHER THE PRODUCTS NOR THE LOT NUMBERS FOR THESE PRODUCTS ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A CURRENTLY (B)(6) FEMALE PATIENT WHO RECEIVED DENTURE ADHESIVE POWDER-DOUBLE SALT (SUPER POLIGRIP DENTURE ADHESIVE POWDER- (B)(4) FOR TWO YEARS FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO SUSPECT MEDICATION INCLUDED DENTURE ADHESIVE POWDER-DOUBLE SALT (DENTU GRIP DENTURE ADHESIVE POWDER (B)(4). SHE STATED THAT SHE NEVER USED SUPER POLIGRIP CREAM, SHE USES SUPER POLIGRIP POWDER. SHE REPORTED THAT SHE HAS HAD DENTURES SINCE (B)(6) AND HAS USED ORAHESIVE AND DENTU GRIP ((B)(4)) IN THE PAST BEFORE BEGINNING USE OF SUPER POLIGRIP. ON AN UNK DATE(S), THE PT STARTED DENTU GRIP AND SUPER POLIGRIP. AT AN UNK TIME AFTER DISCONTINUING DENTU GRIP AND STARTING SUPER POLIGRIP, THE PT EXPERIENCED BACK PAIN, NEUROPATHY, NUMB FEET, LEG NUMBNESS, HAND PAIN, FOOT PAIN, LEG PAIN, BACK PAIN, WALKING DIFFICULTY REQUIRING USE OF A WALKER, RUBBERY LEGS, LOW BACK PROBLEMS, LOW BACK PAIN, AND VERTEBRAL COMPRESSION OF NERVE. THE PT WAS HOSPITALIZED. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. SHE REPORTED THAT SHE HAS HAD A BACK PROBLEM FOR 2 YEARS PRIOR TO THE DATE OF THIS REPORT. ON AN UNK DATE, SHE HAD LOWER BACK PAIN OF HER LOWER BACK AND ON (B)(6) 2009, SHE RECEIVED AN INJECTION IN HER LEFT HIP AT THE OFFICE OF HER ORTHOPAEDIC DOCTOR. IMMEDIATELY, SHE HAD NUMBNESS ON HER FEET AND LEGS, HER LEGS FELT RUBBERY BUT SHE DROVE HOME. SHE REPORTED THAT SHE WAS HOSPITALIZED (B)(6) 2009 DUE TO WORSENING OF THE NUMBNESS OF HER FEET AND LEGS. A MAGNETIC RESONANCE IMAGING (MRI) SCAN REVEALED THAT A VERTEBRAE WAS PRESSING ON A NERVE. SHE WAS DISCHARGED TO A REHABILITATION FACILITY (DATES NOT PROVIDED). IN (B)(6) 2010, SHE UNDERWENT AN UNSPECIFIED SURGERY AND AGAIN WENT TO A REHABILITATION FACILITY. SHE REPORTED THAT SHE HAS NEUROPATHY, DIFFICULTY WALKING, PAIN OF HANDS, FEET LEGS, DATES OF ONSET NOT PROVIDED. SHE REPORTED THAT SHE CONTINUES TO HAVE PAIN OF HER LOWER BACK. SHE REPORTED THAT HER FEET ARE ALWAYS NUMB AND HER LEGS ARE NUMB WHEN SHE LIES DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP POWDER AND DENTU GRIP POWDER DENTURE ADHESIVE POWDER KOL GLAXOSMITHKLINE UNK AND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ORAHESIVE