BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1652816 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00053
    Event Type
    Death
    Date Received
    April 5, 2010
    Report Date
    February 9, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOL
    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. OTC DEVICE.

    Description of Event or Problem · 1

    PROGRESSIVE LOSS OF MUSCLE MOVEMENT, COULD ONLY MOVE EYES [HYPOTONIA]. COULDN'T FEEL FOOT AFTER LIFTING IT HIGH [NERVOUS SYSTEM DISORDER]. DIFFICULTY WALKING [GAIT DISTURBANCE]. LOSS OF BALANCE [BALANCE DISORDER]. LOSS OF USE OF LEGS [LOSS OF CONTROL OF LEGS]. PAIN ALL OVER [PAIN]. COPPER LEVEL LOW [BLOOD COPPER DECREASED]. FELL DOWN [FALL] . URINATED ON SELF [URINARY INCONTINENCE]. LOSS OF USE OF ARMS [MUSCULAR WEAKNESS]. ZINC POISONING [METAL POISONING]. CASE DESCRIPTION: A CONSUMER REPORTED THAT HE WAS 100% POSITIVE THAT HIS FATHER (B) (6), DIED OF ZINC POISONING FROM HIS USE OF FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM. NO FURTHER INFO WAS PROVIDED. ON (B) (6) 2010, CONSUMER RELATIONS FOLLOW-UP PHONE CALL TO CONSUMER: THE CONSUMER REPORTED THAT HIS FATHER HAD USED DENTURE CREAM FOR YRS, USING MORE IN THE LAST FEW YRS BECAUSE HIS DENTURES DID NOT FIT WELL. HE DEVELOPED ALL OF THE SYMPTOMS OF ZINC POISONING WHEN HIS HLTH STARTED TO DECLINE A FEW YRS BEFORE HE DIED. HIS PHYSICIAN TOLD HIM THAT HIS COPPER LEVEL WAS LOW. HIS LEGS STARTED TO GO AND HE HAD DIFFICULTY WALKING AND HE COULD NOT KEEP HIS BALANCE; HE WOULD LIFT HIS LEFT FOOT HIGH AND LOOK AS IT AS IF HE COULD NOT FEEL IT. HE FELL IN THE ROAD ONE DAY AND THE DECISION WAS MADE TO PLACE HIM IN A NURSING HOME WHERE HE WAS RESTRICTED TO A WHEEL CHAIR. HIS FATHER LOST THE USE OF HIS LEGS AND ARMS, URINATED ON HIMSELF, AND COMPLAINED OF PAIN ALL OVER. TREATMENT INCLUDED: IBUPROFEN 800 FOR PAIN AND UNSPECIFIED MEDICATION FOR INCONTINENCE. HIS DOCTORS DID CAT SCANS, MRIS, ALL KINDS OF UNSPECIFIED TESTS, AND NOTHING WAS CONCLUSIVE. HIS FATHER WAS (B) (6) WHEN HE DIED ON (B) (6) 2008. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - NON-SMOKER. THERE WAS NO FURTHER INFO PROVIDED. ON 02/09/2010, SAFETY FOLLOW-UP PHONE CALL TO CONSUMER: THE CONSUMER REPORTED THAT HIS FATHER USED DENTURE CREAM FOR 15-20 YRS. THE FAMILY FIRST NOTICED THAT HIS FATHER WAS WALKING FUNNY. HIS BALANCE AND WALKING CAPABILITIES WERE TESTED AT THE TIME HE WAS ADMITTED TO THE NURSING HOME. THEN HE STARTED LOSING THE USE OF HIS ARMS AND IT JUST PROGRESSED OVER HIS ENTIRE BODY UNTIL HE COULD ONLY MOVE HIS EYES AT THE TIME OF HIS DEATH. 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 NONE KOL PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| S