BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 1849102 · Received September 27, 2010

    Report

    Report Number
    1530449-2010-00116
    Event Type
    Other
    Date Received
    September 27, 2010
    Report Date
    September 7, 2010
    Manufacturer
    PROCTOR & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    PARAPLEGIC [PARAPLEGIA]; NUMBNESS LEGS, FEET AND HANDS [HYPOAESTHESIA]; PARALYSIS IN FINGERS [PARALYSIS]; NEUROPATHY [NEUROPATHY PERIPHERAL]; VASCULITIS [VASCULITIS]; WEAKNESS IN FEET / LEGS [MUSCULAR WEAKNESS]; PAIN IN LEGS / FEET [PAIN IN EXTREMITY]; TINGLING IN LEGS, FEET AND HANDS [PARAESTHESIA]. CASE DESCRIPTION: A REGULATORY AUTHORITY REP REPORTED THAT THEY WERE NOTIFIED BY AN ADULT CONSUMER, AGE AND GENDER UNSPECIFIED, WHO USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 2-3 STRIPS OF APPLICATION, 2 /DAY BEGINNING 1995 THROUGH 2010 TO KEEP DENTURES IN PLACE AND FILL GAPS TO MAKE DENTURES FIT BETTER, AND REPORTED THE FOLLOWING: STARTED FEELING NUMBNESS AND TINGLING FIRST IN LEGS AND FEET AND THEN IN HANDS, THERE WAS PARALYSIS IN THE SMALL FINGERS OF BOTH HANDS BEGINNING 2000, WAS DIAGNOSED WITH NEUROPATHY WHICH DEVELOPED INTO AN EXTREME CASE INCLUDING VASCULITIS, WEAKNESS IN LEGS / FEET AND PAIN IN LEGS / FEET SO BADLY THAT THEY COULD NOT WALK VERY FAR NOR CLIMB MANY STAIRS, AND IS NOW PARAPLEGIC AND CAN ONLY MOVE BY WHEELCHAIR. TREATMENT: UNSPECIFIED. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU DENTURE ADHESIVE KOO PROCTOR & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability