BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK (CALCIUM ZINC GANTREZ SALT 33-59% CE

    MDR report key: 1651939 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00012
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    July 15, 2005
    Report Date
    November 16, 2009
    Manufacturer
    PROCTER & GAMBLE CO
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF PRODUCT WAS NOT PROVIDED BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. ADD'L INFO - (US) OTC DEVICE.

    Description of Event or Problem · 1

    LEUKEMIA [LEUKEMIA]; PASSING OUT [LOSS OF CONSCIOUSNESS]; VOMITING [VOMITING]; WEAKNESS [ASTHENIA]; INABILITY TO WALK [ABASIA]; MDS SYNDROME [MYELODYSPLASTIC SYNDROME]; FAINTING [SYNCOPE]; INABILITY TO STAND [DYSSTASIA]; HIGH ZINC [BLOOD COPPER DECREASED]; PERIPHERAL NEUROPATHY [NEUROPATHY PERIPHERAL]. CASE DESCRIPTION: A REGULATORY AUTHORITY REP REPORTED THAT THEY WERE NOTIFIED THAT AN ADULT CONSUMER, GENDER AND AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE. FORM/VERSION UNK, POLIGRIP DENTURE ADHESIVE, OR SEA BOND DENTURE ADHESIVE DAILY (B)(6) 1997 THROUGH (B)(6) 2009 TO HOLD LOOSE DENTURES AND REPORTED THE FOLLOWING: LEUKEMIA, MYELODYSPLASTIC SYNDROME, PERIPHERAL NEUROPATHY, PASSING OUT, FAINTING, VOMITING, WEAKNESS, INABILITY TO WALK, INABILITY TO STAND, HIGH ZINC, AND ZERO COPPER LEVEL. HEALTH CARE PROFESSIONALS WERE VISITED. TREATMENT: BLOOD TRANSFUSIONS BI-WEEKLY, BLOOD BUILDING INJECTIONS TWICE WEEKLY. VIDAZA CHEMOTHERAPY, AND AGGRESSIVE VITAMIN AND MINERAL INTAKE. THE CASE OUTCOME WAS IMPROVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK (CALCIUM ZINC GANTREZ SALT 33-59% CE DENTURE ADHESIVE KOO PROCTER & GAMBLE CO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R