BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER WERNET'S POWDER

    MDR report key: 2214062 · Received July 20, 2011

    Report

    Report Number
    9681138-2011-00178
    Event Type
    Other
    Date Received
    July 20, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WAS RECEIVED IN CENTRAL SAFETY ON (B)(4) 2011. THE START DATE OF COREGA SUPER POWDER WAS UNKNOWN. COREGA SUPER POWDER WAS DISTRIBUTED IN THE UNITED STATES AS SUPER WERNET'S DENTURE ADHESIVE POWDER, AND NEITHER THE PRODUCT NOR LOT NUMBER OF THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LOSS OF CONSCIOUSNESS IN A (B)(6) FEMALE PATIENT, WHO RECEIVED DENTURE ADHESIVE POWDER-CMC (COREGA SUPER POWDER) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED NO CONCURRENT MEDICATION (NONE). ON (B)(6) 2011, THE PATIENT STARTED DENTURE ADHESIVE POWDER-CMC. ON AN UNKNOWN DATE , THE PATIENT EXPERIENCED "PROGRESSIVE" DYSPHAGIA AND ODYNOPHAGIA. ON (B)(6) 2010, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PATIENT SAID SHE HAD "LOSS OF CONSCIOUSNESS SECONDARY TO THE INABILITY TO SWALLOW FOOD". AS A RESULT OF THE LOSS OF CONSCIOUSNESS, SHE SUFFERED A CONCUSSION AND HEAD INJURY. THE PATIENT WENT TO SEE HER DOCTOR WHO SCHEDULED THE PATIENT FOR AN ENDOSCOPY. AT THE TIME OF REPORTING, THE OUTCOME OF CONCUSSION, DYSPHAGIA AND ODYNOPHAGIA WERE UNKNOWN, THE LOSS OF CONSCIOUSNESS HAD RESOLVED AND THE EVENT OF HEAD INJURY WAS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER WERNET'S POWDER DENTURE ADHESIVE POWDER KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR