BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL

    MDR report key: 1022535 · Received March 20, 2008

    Report

    Report Number
    1530449-2008-00002
    Event Type
    Other
    Date Received
    March 20, 2008
    Report Date
    August 14, 2007
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOL
    PMA / PMN Number
    (US) OTC DEV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF PRODUCT WAS NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT NOW SUFFERS FROM PERMANENT AND DEBILITATING NEUROLOGICAL INJURIES CAUSED BY HER USE OF FIXODENT. A PHYSICIAN DIAGNOSED CLIENT WITH COPPER DEFICIENCY MYELONEUROPATHY IN 2006. THE ATTORNEY REPORTED THAT HIS CLIENT'S ILLNESS AND EXTENSIVE TREATMENT HAS FORCED HER TO STOP WORKING COMPLETELY. SHE IS BOUND TO A WHEELCHAIR AND HAS BEEN ADJUDGED AS DISABLED BY THE SOCIAL SECURITY ADMINISTRATION. EVENTS REVEALED IN MEDICAL RECORDS PROVIDED BY THE REPORTER ARE AS FOLLOWS: MYELONEUROPATHY, ZINC TOXICITY, COPPER DEFICIENCY, BOTTOM OF FEET NUMB, NUMBNESS MOVING UP INTO LEGS, NUMBNESS IN LOWER EXTREMITIES, PARESTHESIAS IN LEGS, TINGLING IN LOWER EXTREMITIES, VISUAL CHANGES, BLURRED VISION, TANDEM WALKING IMPAIRED, ROMBERG SIGN POSITIVE, IMPAIRMENT OF HEEL TO SHIN COORDINATION, POOR COORDINATION, DIFFICULTY WITH AMBULATION, UNABLE TO AMBULATE WITHOUT ASSISTANCE, GAIT AND STATION INDICATES IS UNABLE TO AMBULATE AND IS WHEEL CHAIR BOUND, ATAXIA, BROAD BASED HALTING GAIT, WADDING GAIT, STRAIGHT LEG RAISING TEST ABNORMAL WITH LOCAL BACK PAIN AT 45 DEGREE ANGLE, CONSTANT PAIN IN LOW BACK RADIATION TO LEGS, NON SUSTAINED MYOCLONUS RIGHT LOWER EXTREMITY, SUSTAINED ANKLE CLONUS BILATERALLY, PROFOUND LOSS TO VIBRATORY SENSE IN STOCKING DISTRIBUTION, SENSORY CHANGES IN LOWER EXTREMITIES, ARTHRALGIAS, JOINTS HURT, MARKED DECREASE IN MUSCLE TONE, MUSCLES FEEL WEAK, LEAD PIPE RIGIDITY, MUSCLE RIGIDITY, HYPERREFLEXIA, PERIPHERAL NEUROPATHY, POSITIVE BABINSKI SIGN BILATERALLY, PIN LEVEL AT APPROXIMATELY 5TH LUMBAR LEVEL, DECREASED PAIN BILATERAL 5TH LUMBAR LEVEL AND BILATERAL LUMBAR LEVEL AND BILATERAL 1ST SACRAL LEVEL, DECREASED SENSATION, ANKLE SWELLING, PARAPLEGIA, MYOPATHY, POLYNEUROPATHY, AND IS DISABLED. TREATMENT MENTIONED IN MEDICAL RECORDS INCLUDED: COPPER SUPPLEMENTATION, VITAMIN B12 SUPPLEMENTS, VITAMIN E SUPPLEMENTS, BACLOFEN. THE CASE OUTCOME WAS NOT RECOVERED. PAST MEDICAL HISTORY INCLUDED: DRUG ALLERGY "ASPIRIN", MEDICAL HISTORY: "NAUSEA AND HYPOGLYCEMIA CAUSED BY LEVAQUIN", "RAYNAUD'S SYNDROME", "BLEEDING ULCER IN 1987", "GASTRECTOMY IN 1987", "RECEIVED BLOOD TRANSFUSION IN 1987", "CESAREAN SECTION AND TUBAL LIGATION IN 1984", "TOBACCO USE", "MITRAL VALVE PROLAPSE", "WISDOM TOOTH REMOVAL", "TONSILLECTOMY", "PALPITATION SINCE 1990", "HOSPITALIZATION IN 1984 FOR INTERNAL BLEEDING AFTER SLIPPING ON RUG AND INJURED BACK, RIBS AND SPINE", "RECURRING PANIC ATTACKS", "MOTOR VEHICLE ACCIDENT IN 1999", AND "TRAVERSE FRACTURING AT THE SACRO-COCCYGEAL JUNCTION". CONCOMITANT MEDICATIONS INCLUDED: TENORMIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL DENTURE ADHESIVE KOL PROCTER & GAMBLE MANUFACTURING CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability