MAUDE MDR 5243269

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Patient 1

PRODUCT AND LOT NUMBER NOT PROVIDED BY REPORTER THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME.

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Patient 1

KIDNEY FAILURE [RENAL FAILURE]. NEUROPATHY [NEUROPATHY PERIPHERAL]. INSOMNIA [INSOMNIA]. DIARRHEA [DIARRHOEA]. NAUSEA [NAUSEA]. FELL (AND HIT HEAD) [FALL]. (FELL) AND HIT HEAD [HEAD INJURY]. BURNING SENSATION GUMS [ORAL DISCOMFORT]. FOAMING AT MOUTH [FOAMING AT MOUTH]. DRY MOUTH [DRY MOUTH]. LOSING BALANCE [BALANCE DISORDER]. PERIODS OF CONFUSION [CONFUSIONAL STATE]. SORENESS GUMS [GINGIVAL PAIN]. MUSCLE WEAKNESS; DROPPING ITEMS - MUSCULAR [MUSCULAR WEAKNESS]. PERIODS OF FORGETFULNESS [MEMORY IMPAIRMENT]. SWELLING OF THE FEET [PERIPHERAL SWELLING]. MUSCLES ACHING [MYALGIA]. ABDOMINAL PAIN [ABDOMINAL PAIN]. BLOOD PRESSURE WAS HIGH [HYPERTENSION]. DIZZINESS [DIZZINESS]. LIPS WERE WHITE FROM THE FOAM [LIP DISCOLOURATION]. BURNING SENSATION IN HANDS AND FEET [BURNING SENSATION]. PAIN IN HANDS AND FEET [PAIN IN EXTREMITY]. TINGLING IN HANDS AND FEET [PARAESTHESIA]. NUMBNESS IN HANDS AND FEET [HYPOAESTHESIA]. DIFFICULTY WALKING [GAIT DISTURBANCE]. BURNING SENSATION IN STOMACH [DYSPEPSIA]. VOMITING [VOMITING]. ANEMIC [ANAEMIA]. IMMUNE SYSTEM WAS LOW [IMMUNE SYSTEM DISORDER]. PAIN IN STOMACH [ABDOMINAL PAIN UPPER]. SHORTNESS OF BREATH [DYSPNOEA]. LOW/REDUCED RED BLOOD CELL COUNT [RED BLOOD CELL COUNT DECREASED]. NERVE DAMAGE [NERVE INJURY]. (B)(6) WHICH IS 900 REDUCED TO 800 AND SHE HAD NEVER BEEN BELOW 900 VIRAL LOAD UNTIL NOW [BLOOD (B)(6) RNA DECREASED]. ACHES [PAIN]. WEAKNESS [ASTHENIA]. SORE MOUTH [ORAL PAIN]. STOMACH PROBLEMS [GASTRIC DISORDER]. INTESTINAL BACTERIAL INFECTION [ENTERITIS INFECTIOUS]. CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER WITH (B)(6) WELL CONTROLLED AND RECEIVING TREATMENT SINCE 1998 USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM 1 APPLICATION, ONCE A DAY AS DIRECTED BEGINNING IN (B)(6) 2015, THROUGH (B)(6) 2015 AND REPORTED DEVELOPING KIDNEY FAILURE, NEUROPATHY, INSOMNIA AND NERVE DAMAGE. SHE HAD GOTTEN NEW DENTURES IN (B)(6) 2015 AND CONTINUED TO USE FIXODENT UNTIL HER DENTIST ADVISED HER TO STOP WHEN HER DENTURES WERE ADJUSTED IN (B)(6). THE CONSUMER EXPLAINED THAT HER INITIAL SYMPTOMS INCLUDED BURNING GUMS, FOAMING OF THE MOUTH, AND HER LIPS WERE WHITE FROM THE FOAM. SHE EXPERIENCED A BURNING SENSATION, PAIN, TINGLING, AND NUMBNESS IN HER HANDS AND FEET. SHE BEGAN DROPPING THINGS; SHE HAD MUSCLE WEAKNESS AND MUSCLE ACHES ALL OVER HER BODY. SHE DESCRIBED HAVING DIFFICULTY WALKING, DIZZINESS, PROBLEMS WITH HER BALANCE, BURNING SENSATION IN STOMACH, DIARRHEA, NAUSEA, VOMITING, DRY MOUTH, SORE GUMS AND MOUTH, AND SWOLLEN FEET. SHE HAD EPISODES OF CONFUSION AND FORGETFULNESS, HYPERTENSION, SHORTNESS OF BREATH, AND SHE WAS UNABLE TO DO ANY WORK AROUND HER HOUSE DUE TO HER SYMPTOMS THAT HAD PROGRESSIVELY WORSENED LEADING TO A FALL WHERE SHE HIT HER HEAD ON HER DRESSER, RESCUE WAS CALLED, AND SHE WAS TAKEN TO THE HOSPITAL AND HOSPITALIZED FOR FIVE DAYS. WHILE IN THE HOSPITAL, A STOOL SAMPLE REVEALED SHE HAD AN INTESTINAL BACTERIAL INFECTION. THE CONSUMER'S RED BLOOD CELL COUNT WAS LOW; SHE WAS ANEMIC. HER IMMUNE SYSTEM WAS LOW. HER (B)(6) VIRAL LOAD WHICH IS 900 REDUCED TO 800 AND SHE CLARIFIED SHE HAD NEVER BEEN BELOW 900 VIRAL LOAD UNTIL THIS EXPERIENCE. SHE SAW HER PRIMARY PHYSICIAN AND THE DOCTORS WERE CONCERNED ABOUT HER IMMUNE SYSTEM BEING LOW AND ALL HER HEALTH ISSUES INCLUDING A DIAGNOSIS OF KIDNEY FAILURE. TREATMENT INCLUDED HIGH DOSES OF MEDICATION FOR THE NEUROPATHY, UNSPECIFIED MEDICATION FOR NAUSEA AND VOMITING, ANTIBIOTICS TO TREAT THE BACTERIAL INFECTION IN THE INTESTINES, ANTIHYPERTENSIVES TO TREAT HYPERTENSION, AND B12 INJECTIONS FOR ANEMIA. ALSO, SHE WAS USING A WALKER NOW TO HELP WITH THE WEAKNESS AND BALANCE PROBLEMS. WHILE SHE WAS STILL SHORT OF BREATH, HER BLOOD PRESSURE AND SWELLING IN HER FEET HAD IMPROVED. THE OVERALL CASE OUTCOME WAS IMPROVED. RELEVANT HISTORY: DRUG ALLERGIES TO IBUPROFEN, MELOXICAM, AND TOLMETIN SODIUM. MEDICAL HISTORY: DENTURE WEARER (DENTURES) AND (B)(6) (BEING TREATED FOR (B)(6) SINCE 1998). CONCOMITANT PRODUCT(S): NONE REPORTED. NO OTHER INFORMATION WAS PROVIDED.

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Patient 1

RETURN OF PRODUCT WAS REQUESTED. REPORTER RETURNED PRODUCT SAMPLE ON 23-FEB-2016. PRODUCT INVESTIGATION IS IN PROGRESS.

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Patient 1

ARTHRALGIA; POSITIVE FOR ARTHRALGIAS; JOINT PAIN [ARTHRALGIA]. HEMATURIA [HAEMATURIA]. BILIRUBIN TOTAL DECREASED [BLOOD BILIRUBIN DECREASED]. ANGULAR CHEILITIS [ANGULAR CHEILITIS]. RED BLOOD CELL COUNT DECREASED [RED BLOOD CELL COUNT DECREASED]. HEMOGLOBIN DECREASED [HAEMOGLOBIN DECREASED]. MEAN CELL VOLUME INCREASED [MEAN CELL VOLUME INCREASED]. MEAN CELL HEMOGLOBIN INCREASED [MEAN CELL HAEMOGLOBIN INCREASED]. LYMPHOCYTE PERCENTAGE INCREASED [LYMPHOCYTE PERCENTAGE INCREASED]. GRANULOCYTE PERCENTAGE DECREASED [GRANULOCYTES ABNORMAL]. FATIGUE [FATIGUE]. NIGHT SWEATS INTERMITTENTLY [NIGHT SWEATS]. DOESN'T HAVE MUCH APPETITE [DECREASED APPETITE]. BLOATED STOMACH, WORSE AFTER A MEAL; MILD DISTENDED [ABDOMINAL DISTENSION]. ORAL THRUSH [ORAL CANDIDIASIS]. MILD TENDER TO PALPITATION OVER EPIGASTRIUM AND RIGHT UPPER QUADRANT [ABDOMINAL TENDERNESS]. MALAISE [MALAISE]. SLIGHT YELLOWISH DISCOLORATION OF HARD PALATE (AND LATERAL TONGUE) [ORAL MUCOSAL DISCOLOURATION]. YELLOWISH DISCOLORATION OF LATERAL TONGUE [TONGUE DISCOLOURATION]. BACK PAIN [BACK PAIN]. SENSORY CHANGE, LIGHT TOUCH SENSATION DECREASED TO LEVEL OF MID SHIN ON LEFT AND ANKLE ON RIGHT [SENSORY LOSS]. VIBRATION DIMINISHED (BUT PRESENT AT LEFT FOOT AND NORMAL ON RIGHT) [VIBRATION TEST ABNORMAL]. UNABLE TO ELICIT PATELLAR REFLEXES [AREFLEXIA]. UNABLE TO ELICIT ACHILLES REFLEXES [HYPOREFLEXIA]. ORAL PLAQUES [OROPHARYNGEAL PLAQUE]. DECREASED TEMPERATURE ON LEFT FOOT [TEMPERATURE DIFFERENCE OF EXTREMITIES]. MOUTH SORES [STOMATITIS]. ULCERATIONS ON SOFT PALATE [MOUTH ULCERATION]. DIAPHORESIS [HYPERHIDROSIS]. CHEST PAIN [CHEST PAIN]. SYSTOLIC MURMUR [CARDIAC MURMUR]. ACUTE KIDNEY INJURY [ACUTE KIDNEY INJURY]. DEHYDRATION [DEHYDRATION]. LOW LUNG VOLUMES (WITH BORDERLINE CARDIOMEGALY) [PULMONARY FUNCTION TEST DECREASED]. (LOW LUNG VOLUMES WITH) BORDERLINE CARDIOMEGALY [CARDIOMEGALY]. ZINC POISONING/TOXICITY [METAL POISONING]. BLOOD ALBUMIN DECREASED [BLOOD ALBUMIN DECREASED]. HEMATOCRIT DECREASED [HAEMATOCRIT DECREASED]. HEADACHES [HEADACHE]. DEPRESSION [DEPRESSION]. DYSURIA [DYSURIA]. URINARY FREQUENCY [POLLAKIURIA]. DECREASED CONCENTRATION [DISTURBANCE IN ATTENTION]. AGITATION [AGITATION]. COUGH [COUGH]. SORE THROAT [OROPHARYNGEAL PAIN]. TROUBLE SWALLOWING [DYSPHAGIA]. BLOOD CREATININE INCREASED (PATIENT IN ER FOUND TO HAVE INCREASED CREATININE TO 1.52, LAB RESULT NOT PROVIDED) [BLOOD CREATININE INCREASED]. CASE DESCRIPTION: ON 04-FEB-2016 RECEIVED MEDICAL RECORDS BEGINNING (B)(6) 2015 CONTAINING PATIENT PREOPERATIVE RISK ASSESSMENT FOR SURGERY (TURP-TRANSURETHRAL RESECTION ABLATION OF PROSTATE), SURGERY TURP PROGRESS NOTES, TRANSURETHRAL RESECTION PROSTATE PROCEDURE FOLLOW-UP NOTES, INFECTIOUS DISEASES (B)(6) FOLLOW-UP PHYSICIAN'S NOTE DATED (B)(6) 2015, POST UROLOGY SURGERY PHYSICIAN'S NOTE DATED (B)(6) 2015, INTERNAL MEDICINE PHYSICIAN'S PROGRESS NOTE DATED (B)(6) 2015, INTERNAL MEDICINE PHYSICIAN'S PROGRESS NOTE DATED (B)(6) 2015, INTERNAL MEDICINE PHYSICIAN'S FOLLOW-UP PROGRESS NOTES (B)(6) 2015, EMERGENCY MEDICINE PHYSICIANS' NOTES DATED (B)(6) 2015; HOSPITAL ADMISSION (B)(6) 2015, DISCHARGED (B)(6) 2015, HOSPITALIST PROGRESS NOTES, LABORATORY FINDINGS, HOSPITAL FOLLOW-UP PHYSICIAN'S VISIT ON (B)(6) 2015, INFECTIOUS DISEASE FOLLOW-UP PHYSICIAN VISIT ON (B)(6) 2015, ER VISIT AND PHYSICIAN PROGRESS NOTES ON (B)(6) 2015, INTERNAL MEDICINE PHYSICIAN'S PROGRESS NOTE DATED (B)(6) 2015, LABORATORY VALUES (B)(6) 2015 PROVIDED, AND INFECTIOUS DISEASE FOLLOW-UP PHYSICIAN VISIT DATED (B)(6) 2015 CONTAINING EXACT SAME DOCUMENTATION AS (B)(6) 2015 VISIT WITH MEDICATION CHANGE NOTED (GABAPENTIN DISCONTINUED FROM CONCOMITANT LIST AND LYRICA ADDED): ON (B)(6) 2015 THE PRESENTLY (B)(6), PRESENTED TO THE CLINIC FOR PREOPERATIVE RISK ASSESSMENT PRIOR TO TURP (TRANSURETHRAL RESECTION ABLATION OF PROSTATE USING THE THUNDER BEAT BUTTON). PAST MEDICAL HISTORY LEARNED AS FOLLOWS: ALLERGY: SEASONAL ALLERGIES, DRUG ALLERGIES: IBUPROFEN, MELOXICAM, METHOCARBAMOL, SULFA (SULFONAMIDE ANTIBIOTICS, AND TOLMETIN SODIUM. MEDICAL HISTORIES: REACTIVE AIRWAY DISEASE ON ALBUTEROL, HYPERTENSION TAKING NORVASC, (B)(6) INFECTION AND TAKING COMBIVIR AND KALETRA, MENTAL HEALTH PROBLEMS, BIPOLAR DISORDER, SCHIZOPHRENIA ON SEROQUEL, ECZEMA, CHRONIC BACK PAIN, HYPERLIPIDEMIA, PERIPHERAL NEUROPATHY AND TAKING GABAPENTIN, HYPOTHYROIDISM AND ON LEVOTHYROXINE, ANEMIA, BENIGN PROSTATIC HYPERPLASIA ON FLOMAX AND CURRENT INDICATION FOR HIS SURGERY; GERD AND TAKING PRILOSEC (OMEPRAZOLE), WEARS GLASSES, FULL UPPER, PARTIALS ON BOTTOM; CURRENT SMOKER, PREVIOUS HISTORY OF DRUG ABUSE (POWDER COCAINE); NONE SINCE (B)(6) 2014; DENIED INTRAVENOUS DRUG USE, PREVIOUS SURGERY INCLUDED RIGHT SHOULDER SURGERY AND WISDOM TEETH EXTRACTION. CONCOMITANT PRODUCT(S): FLOMAX 1 CAPSULE, 0.4MG BY MOUTH DAILY, ULTRAM 50 MG TABLET, 1-2 TABLETS BY MOUTH EVERY 6 HOURS AS NEEDED FOR PAIN, KENALOG 0.1% CREAM APPLIED TOPICALLY TWO TIMES DAILY, ALBUTEROL (PROVENTIINENTOLIN) INHALER 2 PUFFS EVERY 4-6 HOURS AS NEEDED, ACETAMINOPHEN 500...

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Patient 1

RETURN OF PRODUCT WAS REQUESTED. REPORTER RETURNED PRODUCT SAMPLE ON (B)(6) 2016. THE CONSUMER RETURNED ONE EMPTY TUBE OF FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL CREAM 2.0OZ. THE PRODUCT WAS RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. THE CONSUMER'S RETURNED PRODUCT WAS PRODUCED (B)(6) 2004. THE RECORDS FOR THIS PRODUCT HAVE SINCE BEEN ARCHIVED. THE TUBE STARTED PRODUCTION IN (B)(6) 2004 FOR GLOBAL CODE ALLOCATION SYSTEM (GCAS) CODE (B)(4). THE INVESTIGATION CONCLUDED THAT BASED ON THE EVIDENCE AND PROVIDED SAMPLE, THE TUBE GCAS WAS RAN IN DIGITAL SPECS TUBE THAT SHOWN AN OBSOLETE DATE OF THE TUBE WAS (B)(6) 2008. WHILE THERE IS NOT AN EXPIRATION DATE FOR THIS PRODUCT IN THE UNITED STATES, THE PRODUCT INVESTIGATION CONCLUSION CODE WAS EXPIRED PRODUCT. PMA/510(K) #K 945200 CONTINUED IN ADDITIONAL INFO SECTION. (B)(4).

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Patient 1

KIDNEY FAILURE [RENAL FAILURE] NEUROPATHY [NEUROPATHY PERIPHERAL] INSOMNIA [INSOMNIA] DIARRHEA; UNCONTROLLED BOWELS [DIARRHOEA] NAUSEA [NAUSEA] FELL (AND HIT HEAD) [FALL] (FELL) AND HIT HEAD [HEAD INJURY] BURNING SENSATION GUMS [ORAL DISCOMFORT] FOAMING AT MOUTH [FOAMING AT MOUTH] DRY MOUTH [DRY MOUTH] LOSING BALANCE [BALANCE DISORDER] PERIODS OF CONFUSION [CONFUSIONAL STATE] SORENESS GUMS [GINGIVAL PAIN] MUSCLE WEAKNESS; DROPPING ITEMS - MUSCULAR [MUSCULAR WEAKNESS] PERIODS OF FORGETFULNESS [MEMORY IMPAIRMENT] CONTINUED IN ADDITIONAL INFO SECTION...

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Patient 1

RETURN OF PRODUCT WAS REQUESTED. REPORTER RETURNED PRODUCT SAMPLE ON 23-FEB-2016. THE CONSUMER RETURNED ONE EMPTY TUBE OF FIXODENT DENTURE CARE DENTURE ADHESIVE CONTROL CREAM 2.0 OZ. THE PRODUCT WAS RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. THE CONSUMER'S RETURNED PRODUCT WAS PRODUCED 21-DEC-2004. THE RECORDS FOR THIS PRODUCT HAVE SINCE BEEN ARCHIVED. THE TUBE STARTED PRODUCTION IN APRIL 2004 FOR GLOBAL CODE ALLOCATION SYSTEM (GCAS) (B)(4). THE INVESTIGATION CONCLUDED THAT BASED ON THE EVIDENCE AND PROVIDED SAMPLE, THE TUBE GCAS WAS RAN IN DIGITAL SPECS TUBE THAT SHOWN AN OBSOLETE DATE OF THE TUBE WAS 23-SEP-2008. WHILE THERE IS NOT AN EXPIRATION DATE FOR THIS PRODUCT IN THE UNITED STATES, THE PRODUCT INVESTIGATION CONCLUSION CODE WAS EXPIRED PRODUCT.

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Patient 1