BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SA

    MDR report key: 2170160 · Received June 24, 2011

    Report

    Report Number
    9681138-2011-00150
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 23, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEW POLIGRIP SA IS MFG IN (B)(4), AND MARKETED UNDER THE TRADE NAME SUPER POLIGRIP FREE IN THE U.S. 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 PHYSICIAN AND DESCRIBED THE OCCURRENCE OF A FOREIGN BODY IN A (B)(6) FEMALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SA) CREAM FOR DENTURES. CONCURRENT MEDICAL CONDITIONS INCLUDED ASTHMA, DIABETES MELLITUS, ISCHEMIC HEART DISEASE AND RHEUMATISM, FOR WHICH THE PT WAS RECEIVING UNSPECIFIED MEDICATIONS. THE PT HAD NO KNOWN ALLERGIES. ON AN UNK DATE, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL). ON (B)(6) 2011, AT APPROX 10:00, THE PT EXPERIENCED ABDOMINAL DISCOMFORT. AT APPROX 17:00, SHE FELT QUEASY AND HAD ABDOMINAL PAIN. THE PT WENT TO A CLINIC AND A DOCTOR CONSIDERED THAT THE PT MAY HAVE ACUTE ABDOMEN AND SUGGESTED THE NEED FOR URGENT SURGERY. AT APPROX 20:00, THE PT WAS TRANSFERRED TO ANTHER HOSPITAL. A CT SCAN REVEALED DILATATION OF THE SMALL INTESTINE. BY THIS TIME, THE ABDOMINAL PAIN HAD RESOLVED. ON (B)(6) 2011, THE PT EXPERIENCED MILD ABDOMINAL PAIN AND FELT QUEASY AGAIN. ON (B)(6) 2011, A SECOND CT SCAN REVEALED AN UNSPECIFIED FOREIGN BODY IN THE SMALL INTESTINE. ON (B)(6) 2011, THE PT UNDERWENT SURGERY AND HAD THE FOREIGN BODY REMOVED. THE FOREIGN BODY WAS A WHITE, FLAT LUMP OF AROUND FOUR CM AND THE PT'S SON CONSIDERED THAT IT LOOKED LIKE POLIGRIP SA. ACCIDENTAL INGESTION WAS REPORTED. THE PT WAS HOSPITALIZED AND THE PHYSICIAN CONSIDERED THE EVENTS TO BE CLINICALLY SIGNIFICANT (OR REQUIRING INTERVENTION). AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. THE PHYSICIAN REPORTED THAT THERE WAS A POSSIBILITY THE PT 'DIAGNOSED POLIGRIP SA' AND THE EVENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW POLIGRIP SA DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R UNSPECIFIED MEDICATIONS - UNK