BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59

    MDR report key: 2625775 · Received June 14, 2012

    Report

    Report Number
    1530449-2012-00027
    Event Type
    Other
    Date Received
    June 14, 2012
    Report Date
    May 15, 2012
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    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. G5: PMA/510(K) #K945200.

    Description of Event or Problem · 1

    PERIPHERAL NEUROPATHY OF BOTH HANDS AND FEET [NEUROPATHY PERIPHERAL]. IRREPARABLE DAMAGE TO NERVOUS SYSTEM [NERVOUS SYSTEM DISORDER]. UNABLE TO FUNCTION DUE TO PAIN IN BOTH HANDS AND FEET [PAIN IN EXTREMITY]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN, UNSPECIFIED TOTAL DAILY USE FOR MANY YEARS, AND CURRENTLY SUFFER PERIPHERAL NEUROPATHY OF BOTH HANDS AND FEET; THE ZINC IN FIXODENT HAS IRREPARABLY DAMAGED HIS NERVOUS SYSTEM AND HE IS UNABLE TO FUNCTION DUE TO THE PAIN IN BOTH HANDS AND FEET. THE CONSUMER REPORTED THAT HE HAS BEEN DISABLED 100% FOR THE PAST SEVERAL YEARS, CAN NO LONGER WORK, AND HAS GONE FOR UP TO 72 HOURS WITHOUT MEANINGFUL SLEEP DUE TO THE PAIN. HE MENTIONED THAT HE IS EXPERIENCING SIDE EFFECTS OF THE MEDICATIONS HE MUST TAKE DUE TO THE DAMAGES CAUSED BY FIXODENT. TREATMENT: MORPHINE 3 TIMES DAILY, UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability