BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (VARIANT UNK)

    MDR report key: 1812568 · Received August 16, 2010

    Report

    Report Number
    9681138-2010-00295
    Event Type
    Other
    Date Received
    August 16, 2010
    Report Date
    August 16, 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

    CONSUMER STATED THAT SHE IS UNCERTAIN IF THE SUPER POLIGRIP MAY HAVE PLAYED A ROLE IN HER BREAKING HER FOOT. 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 FOOT FRACTURE IN A (B)(6) FEMALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP ORIGINAL DENTAL ADHESIVE CREAM, THE PT EXPERIENCED FOOT FRACTURE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). CREAM WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other