BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE

    MDR report key: 1651949 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00057
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    January 1, 2006
    Report Date
    November 16, 2009
    Manufacturer
    PROCTER & GAMBLE MFG 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 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

    NEUROPATHY (PROVISIONAL DIAGNOSIS) [NEUROPATHY PERIPHERAL]. PARALYZED [PARALYSIS]. NUMBNESS IN EXTREMITIES [HYPOAESTHESIA]. TINGLING IN EXTREMITIES, TINGLING HANDS AND FEET [PARAESTHESIA]. ABNORMAL CONDITION OF THE NERVES (PROVISIONAL DIAGNOSIS) [NERVOUS SYSTEM DISORDER]. LOW LEVELS OF COPPER ON BLOOD TEST [BLOOD COPPER DECREASED]. HIGH LEVELS OF ZINC ON BLOOD TEST [BLOOD ZINC INCREASED]. MUSCLE WEAKNESS [MUSCULAR WEAKNESS]. LOSS OF BALANCE [BALANCE DISORDER]. LOSS OF COORDINATION [COORDINATION ABNORMAL]. CASE DESCRIPTION: A REP OF A REGULATORY AUTHORITY REPORTED THAT THEY CONTINUED IN ADDITION INFO SECTION WERE NOTIFIED THAT AN ADULT, AGE AND GENDER UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM CONCURRENTLY WITH FASTEETH AND POLIGRIP 1 APPLICATION TWICE A DAY AS DENTAL ADHESIVES (B)(6) IN 1969 TO (B)(6) 2009 AND REPORTED THE FOLLOWING: TINGLING HANDS AND FEET (B)(6) IN 2002, NUMBNESS IN EXTREMITIES, MUSCLE WEAKNESS, LOSS OF BALANCE, AND LOSS OF COORDINATION (B)(6) IN 2003, BECAME PARALYZED IN 2004, AND DIAGNOSED WITH NEUROPATHY IN 2006. THE CONSUMER ALSO REPORTED A DIAGNOSIS OF AN ABNORMAL CONDITION OF THE NERVES. BLOOD TEST RESULTED IN LOW LEVELS OF COPPER AND HIGH LEVELS OF ZINC. THE CONSUMER HAS RECEIVED UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - FULL DENTURE WEARER SINCE 1969. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE NONE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability