BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2249695 · Received August 24, 2011

    Report

    Report Number
    9681138-2011-00213
    Event Type
    Other
    Date Received
    August 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 23, 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

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ARM WEAKNESS IN A MALE PATIENT 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 PATIENT START GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED ARM WEAKNESS, LOWER EXTREMITY WEAKNESS AND GASTRIC DISORDER. THE PATIENT WAS HOSPITALISED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. CONSUMER REPORTED THAT HE WAS USING SUPER POLIGRIP AND HAD STOMACH PROBLEMS IN (B)(6) 2011. HE STATED THAT HE LOST THE STRENGTH IN HIS ARMS AND LEGS AND WAS ADMITTED TO THE HOSPITAL FOR 1 WEEK ON (B)(6) 2011. NO FURTHER INFORMATION WAS PROVIDED.

    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 Hospitalization