BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 541201 · Received August 30, 2004

    Report

    Report Number
    9681138-2004-00017
    Event Type
    Other
    Date Received
    August 30, 2004
    Report Date
    August 12, 2004
    Manufacturer
    GSK
    Product Code
    KOP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WHO RECEIVED POLIGRIP (SUPER POLIGRIP EXTRA CARE WITH POLISEAL) OVER A PERIOD OF 4 MOS FOR LOOSE DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PT'S PAST MEDICAL HISTORY INCLUDED ALLERGY TO MORPHINE, ANGINA PECTORIS, ANGIOPLASTY, ASTHMA AND CODEINE ALLERGY. CONCURRENT MEDICATIONS INCLUDED HYDROCODONE, BEXTRA, HYDROCHLOROTHIAZIDE AND INHALERS. IN 2004 THE PT STARTED POLIGRIP (DENTAL). AT AN UNK TIME AFTER STARTING POLIGRIP, THE PT WAS DIAGNOSED WITH POSSIBLE METASTATIC CANCER; PT HAD TWO BIOPSIES PERFORMED IN 2004 AND WAS HOSPITALIZED OVERNIGHT. THE PT ALSO EXPERIENCED GUM PAIN AND POLIGRIP WAS DISCONTINUED; THIS EVENT IS UNRESOLVED.

    Description of Event or Problem · 1

    MFR'S COMMENT: THE MFR REPORT NUMBER FOR THIS CASE IS 9681138-2004-00017. SUPER POLIGRIP EXTRA CARE WITH POLISEAL IS MANUFACTURED. IN THE ABSENCE OF FURTHER DATA OR SUPPORTIVE TRENDS, QUALITY TESTING IS UNLIKELY TO CLARIFY THE ADVERSE EVENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP DENTURE ADHESIVE KOP GSK * R03494

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O 2. BEXTRA, UNK,| 3. HYDROCHLOROTHIAZIDE, UNK,| 4. INHALER, UNK.| 1. HYDROCODONE, UNK,