BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33% CELLUL

    MDR report key: 2223823 · Received August 18, 2011

    Report

    Report Number
    1530449-2011-00130
    Event Type
    Other
    Date Received
    August 18, 2011
    Report Date
    August 2, 2011
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING 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

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ZINC TOXICITY [METAL POISONING]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. EXTREME MUSCLE WEAKNESS [MUSCULAR WEAKNESS]. EXTREME MUSCLE SPASMS [MUSCLE SPASMS]. NUMBNESS [HYPOAESTHESIA]. TINGLING [PARAESTHESIA]. BALANCE PROBLEMS [BALANCE DISORDER]. DIFFICULTY WALKING [GAIT DISTURBANCE]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, NOW (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM, UNSPECIFIED TOTAL DAILY USE BEGINNING 2007 THROUGH (B)(6) 2011, AND/OR SUPER POLIGRIP DENTURE ADHESIVE, UNSPECIFIED TOTAL DAILY USE BEGINNING 2007 THROUGH (B)(6) 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE EXTREME MUSCLE WEAKNESS AND EXTREME MUSCLE SPASMS, NUMBNESS AND TINGLING, BALANCE PROBLEMS AND DIFFICULTY WALKING. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE 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, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33% CELLUL DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability