BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1943528 · Received December 2, 2010

    Report

    Report Number
    9681138-2010-00403
    Event Type
    Other
    Date Received
    December 2, 2010
    Report Date
    December 1, 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

    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 INJURY IN A MALE PT WHO USED POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING POLIGRIP. AN UNK TIME LATER, THE PT EXPERIENCED UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. MEDICAL RECORDS RECEIVED (B)(6) 2010: ON (B)(6) 2010, THE (B)(6) PT WAS SENT FOR POSSIBLE NEUROPATHY. OVER THE FOUR TO FIVE MONTHS PRIOR, HE HAD BEGUN TO HAVE SLOW ONSET OF NUMBNESS AND TINGLING BEGINNING IN HIS TOES AND SPREADING UP HIS FEET. HE ALSO HAD WALKING AND GAIT/BALANCE DIFFICULTIES. THE PT WAS NOTED TO HAVE A HISTORY OF SEVERE STOMACH PROBLEMS WITH ONLY ONE-FOURTH OF HIS STOMACH REMAINING AFTER PEPTIC ULCER DISEASE WITH JEJUNOSTOMY AND FEEDING TUBE PLACEMENT. EMG/NERVE CONDUCTION STUDY OF THE LOWER EXTREMITIES BILATERALLY REVEALED EVIDENCE FOR A SENSORY MOTOR NEUROPATHY. AT FOLLOW UP ON (B)(6) 2010, IT WAS NOTED THAT THE PATIENT'S COPPER LEVEL WAS 9 MCG/DL (NORMAL 71 TO 75) AND THERE WAS A SLIGHTLY ABNORMAL SERUM PROTEIN IMMUNOFIXATION. HE WAS STARTED ON COPPER SUPPLEMENTATION AT THAT TIME. ON (B)(6) 2010, COPPER WAS 10 MCG/DL (NORMAL 70 TO 155) AND ZINC WAS 120 MCG/DL (NORMAL 70 TO 150). ON (B)(6) 2010, THE PT WAS SEEN FOR SUSPECTED MONOCLONAL GAMMOPATHY AND FURTHER WORK-UP WAS RECOMMEND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other