BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2509502 · Received March 23, 2012

    Report

    Report Number
    1530449-2012-00012
    Event Type
    Other
    Date Received
    March 23, 2012
    Report Date
    March 14, 2012
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    NOW SUFFERS FROM PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER], SEVERE AND PERMANENT PHYSICAL INJURIES, AND OTHER INJURIES [INJURY], NEUROPATHY [NEUROPATHY PERIPHERAL], EXCESS ZINC [HYPERZINCAEMIA], COPPER DEPLETION [COPPER DEFICIENCY], ZINC POISONING [METAL POISONING]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT A (B)(6) MALE CLIENT USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK, UNSPECIFIED TOTAL DAILY USE TO SECURE HIS DENTURES THAT HE RECEIVED APPROX 17 YEARS AGO, AND REPORTED THE FOLLOWING: NOW SUFFERS WITH PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, AND OTHER INJURIES THAT HAVE LEFT HIM UNABLE TO PERFORM NORMAL, CUSTOMARY AND DAILY ACTIVITIES; DIAGNOSED WITH NEUROPATHY ATTRIBUTED TO EXCESS ZINC, COPPER DEPLETION, AND ZINC POISONING. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED CONTINUING MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. THE CUSTOMER DISCONTINUED USE OF FIXODENT. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - RECEIVED HIS DENTURES APPROX 17 YEARS AGO. 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 MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability