MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-11 for FIXODENT DENTURE ADHESIVE, CONTROL PLUS SCOPE FLAVOR manufactured by Proctor & Gamble Manufacturing Co..
[74907618]
Lot number or product was not provided by the reporter and case concerns long-term product use.
Patient Sequence No: 1, Text Type: N, H10
[74907619]
Three (3) strokes; history of cva (cerebrovascular accident). Can't eat/ trouble eating [dysphagia]. Trouble speaking [aphasia]. Can't walk/ trouble walking [abasia]. Copper level down to 7 [blood copper decreased]. Numbness - legs, numbness in lower extremities [hypoaesthesia]. Tingle - legs, tingling in lower extremities [paraesthesia]. Zinc toxicity, zinc intoxication [metal poisoning]. Can't move hands [peripheral paralysis]. Pain from neuropathy [neuralgia]. Permanently damaged nerve endings [nerve injury]. Severe lower extremity weakness; muscle strength -4/5 and symmetric in the upper limbs, 3/5 strength in the proximal lower limbs, 2/5 at best in the distal lower limbs [muscular weakness] loss of sensation in lower extremities, decreased sensation over her entire right side [sensory loss]. Neuropathy in lower extremities, peripheral neuropathy [neuropathy peripheral]. Paralyzed from the waist down [paraplegia. ] loss of bowel function [anal incontinence]. Loss of bladder function [urinary incontinence]. Severe copper deficiency [copper deficiency]. High levels of zinc secondary to denture cream overuse [blood zinc increased]. Copper deficiency myeloneuropathy [myelopathy]. Length dependent, motor-sensory, peripheral polyneuropathy [peripheral motor neuropathy]. Polyneuropathy [polyneuropathy]. Nerve conduction studies abnormal [nerve conduction studies abnormal]. Electromyogram abnormal [electromyogram abnormal]. Neurological examination abnormal [neurological examination abnormal]. Case description: a (b)(6) female consumer reported via phone on 16-feb-2017 that she used fixodent denture care denture adhesive control plus scope flavor cream scope flavor, beginning on an unspecified date, and had a stroke, had trouble eating, could not walk or eat, numbness and tingling in her legs with her right side being worse than the left, and her copper level was down to 7. She reported the trouble speaking, walking, and eating started about a month after product use, and she was unsure when her copper level dropped or when the tingling and numbness began. The stroke occurred 7 years after using the product. She stated her doctor had never seen the copper level below 50. The consumer reported she had spoken to several doctors, and they did not know what was going on until one doctor said it was from the fixodent product and overuse of the product. The consumer stated she had used the product as directed once a day. She reported a nurse told her the product was being effected by her gastric bypass and not getting to the area it was supposed to reach. The consumer was given copper to take by mouth, and told to watch her zinc intake. She was told to use a product that was not made with zinc, and she reported she stopped using the fixodent about 2 years ago. The consumer reported she had been hospitalized 3 to 4 times. She spent 3 to 4 days in the hospital each time, and was sent to a rehab center. The case outcome was not recovered/ not resolved. Relevant history: allergies to peanuts, strawberries, and sulfa drugs. Concomitant product(s): none reported. No further information was provided. On 13-mar-2017 follow-up with consumer via phone: the consumer reported her husband will have to fill out her medical questionnaire for her because she cannot move her hands. No further information was provided. On 12-apr-2017 received consumer's follow-up questionnaire and medical records: questionnaire completed by consumer's spouse on 05-apr-2017 reported that the consumer, current (b)(6) began using fixodent scope flavor, once daily as directed on box for denture adhesive for upper and lower full dentures, beginning approximately in 2007. The product was used over 2 years before the problem occurred. Product use was stopped when the consumer was diagnosed with zinc toxicity on (b)(6) 2014. The problem was described as "whole body, cannot walk or use hands" beginning on an unknown date and is ongoing. A physician was visited, and the consumer had been to the emergency room several times over the years due to associated zinc toxicity. The reporter stated the zinc in adhesive depleted copper levels which permanently damaged nerve endings, and doctors said it was not curable. The problem was not resolved, and there is no treatment. There had been no similar problem in the past. The consumer was currently under the care of a physician. Current or past medical conditions included seizures, neuropathy, "knees," vagus nerve stimulator (vns), gastric bypass. Allergies included sulfa with reaction of swell up with hives, adhesive tape with reaction of rash, and peanut butter with reaction of rash on face and seizures. Medications taken at the time the problem began included: oxycodone 10 mg, 1 daily for pain from neuropathy; klonopin 1 mg, 3/day for anxiety; cymbalta 60 mg, 1/daily for depression/pain; abilify 30 mg, 1/daily for bipolar; strattera 100 mg, 1/morning for adhd. The case outcome was not recovered/ not resolved. No further information was provided. Medical records from (b)(6) 2014 encounter: the patient was seen in a medical center on (b)(6) 2014 with chief complaint of weakness and loss of sensation in lower extremities. History of present illness (hpi): patient is a 52 year old female presenting for second opinion on previously diagnosed neuropathy in her lower extremities. It began as numbness and tingling in her lower extremities in 2008 when she needed a walker to get around. By 2011 she was paralyzed from the waist down, needed a wheelchair to get around, and developed loss of bowel and bladder function. She regained control of her bowel and bladder, as well as some movement in her lower extremities. She has physical therapy (pt) once per week, and has been able to stand at pt with assistance for the past month. She reports decreased sensation over her entire right side. She has had 3 strokes, with the last one in (b)(6) 2012 which was "behind my left ear. " she had a motor vehicle accident (mva) in 1982 which resulted in the placement of an acrylic plate on the left side of her skull. She developed seizures which were uncontrolled until 2010 when she had a vagus nerve stimulator placed. Now she has occasional absence and right sided seizures per an eeg reading. She reports 3 migraines per week for which she takes rizatriptan then toradol for abortive therapy and topiramate for prophylaxis. She also reports some confusion and memory loss since the accident, but she has noticed a definite decrease over the last 8 years. She reports a history of schizophrenia and bipolar disorder which have required hospitalizations in the past. She still has visual hallucinations but acknowledges they are not real and are not distressing like in the past. Review of labs from june show a severe copper deficiency and high levels of zinc secondary to denture cream overuse. Review of systems: the complete 12 system review of systems was obtained was negative aside from that mentioned in the hpi. Active problems: anemia; extremity atherosclerosis with intermittent claudication; history of cva (cerebrovascular accident); joint pain, knee; pre-operative cardiovascular examination. Cardiovascular exam: regular heart rate and rhythm. S1, s2, no murmur. Carotid arteries no carotid bruits. Blood pressure 105/71, heart rate 96 beats per minute. Neurological examination: patient is alert and oriented. Speech is clear and language is normal. Cranial nerves normal. Deep tendon reflexes symmetrical in all four extremities, plantar responses are flexor bilaterally. Coordination intact finger-to-nose, heel-to-shin, and rapid alternating movements, no tremor. Sensation intact to light touch, vibration, pin-prick with marked distal decrement. Routine gait was unable to be assessed due to the patient has severe lower extremity weakness. Muscle strength: strength -4/5 and symmetric in the upper limbs. Patient has 3/5 strength in the proximal lower limbs. 2/5 at best in the distal lower limbs. Assessment: 1. Peripheral neuropathy 2. Copper deficiency myeloneuropathy. The patient has myeloneuropathy secondary to severe copper deficiency secondary to zinc intoxication from denture cream. Plan for copper deficiency myeloneuropathy: requested ceruloplasmin, copper serum, and zinc serum for (b)(6) 2014. Plan for copper deficiency myeloneuropathy, peripheral neuropathy: electromyogram (emg)-nerve conduction study. Recheck serum copper and ceruloplasmin, check zinc, avoid zinc containing denture creams and products, emg and nerve conduction study of in upper and lower limb. Treatment options with supplemental copper at length were discussed with the patient. Results from (b)(6) 2014 laboratory tests: blood zinc (range: low-56 ug/dl, high-134 ug/dl): 131 ug/dl (normal); ceruloplasmin (range: low-16. 0 mg/dl, high-45. 0 mg/dl): 30. 0 mg/dl (normal). Relevant history: former smoker. Allergies to aspirin tabs, nsaids, and sulfa drugs. Surgical history of high gastric bypass. Current medications: atorvastatin calcium; baclofen; calcium; cetirizine; iron; lasix; levothyroxine sodium; lyrica; morphine sulfate; nexium; percocet; plavix; potassium chloride; prenatal vitamins; clonazepam; cymbalta; abilify; strattera. The overall case outcome was improved. No further information was provided. Emg laboratory results: the patient was seen for testing on (b)(6) 2015. Patient history included copper deficiency, and severe neuropathy. Nerve conduction studies were performed in the left upper extremity and left lower extremity. A needle emg of the left upper and lower extremity was performed. The left median motor study recording the abductor pollicis brevis showed a normal amplitude, normal latency, and normal conduction velocity. The left ulnar motor study recording the abductor digiti minimi showed a normal amplitude, normal latency, and normal conduction velocity. No conduction block or focal slowing was present across the elbow. The left ulnar minimal f-wave latency was normal. The left median minimal f-wave latency was normal and was not prolonged compared to the ulnar. The left median sensory study recording digit two showed a low amplitude, prolonged latency, and slow conduction velocity. The left ulnar sensory study recording digit five showed a low amplitude, prolonged latency, and slightly slow conduction velocity. The left radial sensory study recording the anatomic snuffbox showed a normal amplitude, normal latency, and borderline conduction velocity. The left peroneal motor study recording the extensor digitorum brevis showed an absent response. The left tibial motor study recording the abductor hallucis brevis showed an absent response. The left sural sensory study showed an absent response. The left superficial peroneal sensory study showed an absent response. Conclusion: this is an abnormal study demonstrating a length dependent, motor-sensory, peripheral polyneuropathy. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00002 |
| MDR Report Key | 6559690 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-11 |
| Date of Report | 2017-02-16 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENT DENTURE ADHESIVE, CONTROL PLUS SCOPE FLAVOR |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-05-11 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTOR & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | BROWN SUMMIT NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2017-05-11 |