BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2163560 · Received June 2, 2011

    Report

    Report Number
    1530449-2011-00097
    Event Type
    Other
    Date Received
    June 2, 2011
    Report Date
    May 9, 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
    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.

    Description of Event or Problem · 1

    POLYNEUROPATHY [POLYNEUROPATHY]. NEUROPATHY IN LEGS AND ARMS, STARTED IN FEET AND WENT TO KNEES [NEUROPATHY PERIPHERAL]. CAN NOT WALK, IN A WHEELCHAIR [ABASIA]. ZINC AND COPPER POISONING [METAL POISONING]. CAN NOT SLEEP AT NIGHT BECAUSE IT IS LIKE WHOLE BODY IS ON FIRE, BURNING SENSATION FEET TO KNEES [BURNING SENSATION]. COULD NOT FEEL FEET AND MOVED TO KNEES, ARMS AND FINGERS [SENSORY LOSS]. PUT FEET ON FLOOR ONE DAY AND WENT DOWN [MUSCULOSKELETAL DISORDER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLIC, 1/DAY FROM 1994 THROUGH 2008 AND REPORTED THE FOLLOWING: NEUROPATHY IN LEGS AND ARMS, STARTED IN FEET AND WENT TO KNEES, HAVE NOT BEEN ABLE TO WALK FOR THE PAST 3 YEARS BEGINNING 2008, ZINC AND COPPER POISONING, CANNOT SLEEP AT NIGHT BECAUSE IT IS LIKE WHOLE BODY IS ON FIRE. HER DOCTORS SAY THERE IS NO CURE. TREATMENT: GABAPENTIN 300 MG 3/DAY AND 600 MG AT NIGHT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: DRUG ALLERGY - PENICILLIN, IODINE, AND MERCURY. CONCOMITANT MEDICATIONS INCLUDED: ANALGESIC AND GABAPENTIN. NO FURTHER INFORMATION WAS PROVIDED. (B)(6), 2011 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT ON (B)(6) 2011: THE CONSUMER REPORTED THAT SHE HAS NO FEELING IN HER FEET: SHE PUT HER FEET ON THE FLOOR ONE MORNING AND WENT DOWN; THE SYMPTOM MOVED FROM HER FEET TO HER KNEES, ARMS, AND FINGERS; SHE CAN'T WALK AND IS NOW IN A WHEELCHAIR, STUCK IN HER ROOM FROM THE WHEELCHAIR TO THE BED. SHE REPORTED THAT THE PAIN THAT SHE GETS IS A BURNING SENSATION FROM HER KNEES UP. SHE VISITED HER PHYSICIAN WHO SAID SHE HAS POLYNEUROPATHY. TREATMENT: PHYSICAL THERAPY, HOME CARE, IS TRYING TO LEARN HOW TO WALK AGAIN WITHOUT FEELING HER FEET, LORTABS, HOUSE HAS BEEN REMODELED FOR HANDICAPPED. NO FURTHER INFORMATION 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 DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability GABAPENTIN (GABAPENTIN)| ANALGESIC (TROLAMINE SALICYLATE)