BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2163650 · Received June 17, 2011

    Report

    Report Number
    9681138-2011-00144
    Event Type
    Other
    Date Received
    June 17, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PERIPHERAL NEUROPATHY IN A (B)(6) OLD FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (SUPER POLIGRIP) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PT EXPERIENCED PERIPHERAL NEUROPATHY, NAIL PAIN, FINGER PAIN AND TOE PAIN. TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. ORIGINAL CONTACT WAS NOT AN AE REPORT. FOLLOW UP RECEIVED ON (B)(6) 2011 CONTAINED ADVERSE EVENTS OF PERIPHERAL NEUROPATHY, PAIN IN NAIL BEDS, PAIN IN FINGERS AND PAIN IN TOES. THE USE OF SUPER POLIGRIP WAS DISCONTINUED. AE FOLLOW UP RECEIVED VIA E MAIL (B)(6) 2011 THAT UPGRADED THE CASE TO SERIOUS: CONSUMER REPORTED THAT SHE HAD BEEN DIAGNOSED WITH PERIPHERAL NEUROPATHY AT THE AGE OF (B)(6). CONSUMER ALSO REPORTED THAT SHE SUFFERS FROM RENAL FAILURE. THIS CASE IS CONSIDERED MEDICALLY SERIOUS BY GSK. OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other