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Event Type  Other  
Manufacturer Narrative

Lot number or product was not provided by the reporter, therefore unable to proceed with batch retain testing or product investigation.

Event Description

Uneven balance, balance problems [balance disorder], vomiting, projectile vomiting [vomiting projectile], falling [fall], potassium is high [blood potassium increased], cannot drive or participate in activities [decreased activity], device misuse (uses fixodent at least 2x a day due to misfitting dentures) [device misuse], severe nausea [nausea], digestive problems [dyspepsia], gagging [retching], constipation [constipation], dizziness [dizziness], loss of taste [ageusia], loss of smell [anosmia], unable to walk for a time, unable to walk without support, gait unstable [gait disturbance], dts (delirium tremens) [delirium tremens], lost 60 pounds [weight decreased], could not eat, loss of appetite [decreased appetite], poor sleep habit [poor quality sleep], dehydrated [dehydration], spastic shakes, tremors, hand tremors [tremor], feet and leg pain, myalgia [myalgia], walking with cane [mobility decreased], abdominal pain [abdominal pain], tingling right arm [paraesthesia], weakness [asthenia], numbness right arm [hypoaesthesia], fatigue [fatigue], loss of affect, blunt affect [blunted affect], weakness of extremities [muscular weakness], dry mouth [dry mouth], dry tongue [tongue dry], dry skin [dry skin], night sweats [night sweats], dysphagia [dysphagia], unable to sleep, insomnia [insomnia], severe pain running down left arm [pain in extremity], unusual pain right side of jaw [pain in jaw]. Case description: a consumer reported that they, an elderly female (b)(6) years, used fixodent denture adhesive, original cream at least twice daily due to misfitting dentures (device misuse), and has been to see her physician and to the emergency room several times in the past year regarding the following: uneven balance / balance problems, falling, and vomiting; her potassium is high, she cannot drive or participate in activities. They do not know what is wrong with her; her vitals are okay but she has not been tested for zinc. The case outcome was not recovered/not resolved. Past medical history included: medical history - denture wearer since (b)(6). Concomitant medications included: numerous medications (unspecified). No further info was provided. On (b)(6) 2011, received consumer's f/u phone call: the consumer reported that she had been experiencing severe nausea, lasting an hour or so, every night at the same time. She had a zinc level drawn on (b)(6) 2011 and it came back normal. The consumer discontinued use of fixodent on (b)(6) 2011 and feels much better. No further info was provided. On 12/22/2011, received consumer's f/u questionnaire: the consumer reported that she used fixodent original and/or fixodent denture adhesive, fresh, fixodent denture adhesive, free, fixodent denture adhesive, food seal, flavor unk several times daily for many years, last known use several months ago. Additional symptoms experienced for several years included digestive problems, gagging, constipation, dizziness, loss of taste, loss of smell, unable to walk for a time / unable to walk without support, delirium tremens, could not eat / loss of appetite, lost 60 pounds, every day just before night she would get real sick / moaning and groaning, had a poor sleep habit, and was dehydrated each time she went to the hospital even though she was taking fluids. She has had many doctor visits and spent time in the hospital with all tests and labs returned negative; her physicians were puzzled because she did not have pain and they could not find nothing to treat. Within a week of not using fixodent she began to notice a change: she stopped falling and her appetite returned. The cause outcome was improved. Past medical history included: drug allergy - codeine, medical history - diabetic, high blood pressure, arthritis, parkinson's disease / her doctor has advised her she never stay home alone, has been medically tested allergies. No further info was provided. On 1/20/2012: received physician letter: the physician reported that he had reviewed their records and could find nothing to indicate any complaint regarding fixodent. No further info was provided. On 2/27/2012: received medical records from primary are physician: (b)(6) 2011: pt seen in office for diabetes eval. (b)(6) pounds. The pt was seen in the emergency room recently where she was told her sugar had dropped too low. The pt is on metformin twice daily and glipizide once daily. Non fasting blood sugar was 225 and hemoglobin a1c was 5. 2. Daily glipizide was discontinued. The pt continues to take both blood pressure and hyperlipidemia medication. Assessment: hyper tension, hyperlipidemia and diabetes mellitus. On (b)(6) 2011: pt seen in office for f/u after emergency room visit that occurred 4 days ago. (b)(6) pounds. She went to the emergency room for complaints of nausea, vomiting and abdominal pain and had a final diagnosis of cystitis. The pt had another episode of nausea and vomiting on (b)(6) 2011. The pt reported that her sugars are running high again. Examination revealed clear speech with some loss of affect, abdomen protuberant but non tender, lower extremities are normal, pt indicates some walking difficulty and is using her walking stick at this point. Random blood sugar fasting at 154. The pt reported lately being too weak and ill to go to the daily sensor citizens lunch. Assessment: diabetes mellitus (poor control) and hypotension. Plan: stop azilect, stop hctz, decrease simvastatin 200mg daily, refill glipizide 10 mg daily, amlodipine 5 mg daily, nexium 40 mg daily, metformin 1000mg twice a day, add zofran 4 mg every 6 hours as needed, cipro 500 mg twice a day for seven days, increase fluids, rest and to er if worsening or no improvement. On (b)(6) 2011: pt seen in office for f/u after being hospitalized from (b)(6) 2011. (b)(6) pounds. The pt reports initially being hospitalized for constipation and the discharge summary indicates she was treated for a multiplicity of problems including a bladder infection that they did not find until she was leaving the hospital. During the course of her hospitalization the pt reports she was given fluids, had several enemas and was given an unk liquid to drink to help her bowels move. The pt reported having a good bowel movement but continues to complain of being extremely weak. Random blood sugar was 180. The pt also complains of dry mouth and skin; visual examination appears to suggest that she is dehydrated. Assessment: review for systems done except dry mouth, loss of several pounds of weight and her current bladder problem. There is essentially nothing new in her review of systems. On (b)(6) 2011: telephone call from the pt to office revealed the pt got approved for assisted living. The pt states that she unable to bathe herself and forgets medication, unable to fix food for herself, dizzy when standing. Pt reports unable to care for self. On (b)(6) 2011: pt seen in office for 3 month exam. (b)(6) pounds. Allergy codeine. Pt reporting metformin makes her start vomiting. Blood sugar at home 166. Hemoglobin aic was 5. 9. Examination revealed mouth and tongue appears dry. Neurologically the pt appears intact although her gait is unstable. Lower extremities examined and are warm and well profused with no evidence of edema although the pt appears somewhat dehydrated. Review of pt's diabetic history and recommends the pt give up sweets and sweet tea. Assessment: hypertension (good control), diabetes (uncontrolled), constipation (improved), cystitis (under treatment), dehydration, and dry mouth. On (b)(6) 2011: the pt presents with strange tingling in right arm over one week. (b)(6) pounds. The pt has not been taking medications as prescribed by the neurologist for parkinsons. Gait smooth and coordinated; walks with cane. Pt reports that she stopped taking metformin since her last visit and it makes her sick at her stomach; she continues to take the glipizide. Random blood sugar 166 and hemoglobin a1c was 5. 7. Assessment: numbness right arm, parkinsons, diabetes, hyper tension, fatigue. Plan: advise pt to start taking medication as prescribed by neurologist. Continue on glipizide and re-evaluate in one month. On (b)(6) 2011: the pt presents with complaints of vomiting last night and continues to be extremely nauseated today, denies diarrhea but has some constipation, night sweats and discomfort with urination. (b)(6) pounds. Pt was discharged from nursing home recently because she had been feeling well. Urinalysis performed in office within limits. Assessment: fatigue, nausea, vomiting, night sweats, diabetes and dysuria. Extreme fatigue and night sweats attributed to the pt's use of phenergan. Pain: prescription for zofran, continue as scheduled with specialist for kidney function monitoring, advised pt to increase fluids as this might be the case of dysuria and discomfort with urination. On (b)(6) 2011: the pt complains of being unable to sleep at night and has increased fatigue. Weight (b)(6). The pt has recently been seen in the emergency room for nausea and vomiting, she has had several scans and x-rays of abdomen. The pt was offered an egd but refused. Assessment: insomnia, fatigue, and diabetes. Plan: ambien 10mg hs and f/u with gastrologist as previously scheduled. On (b)(6) 2011: pt reported feels like she is having a reaction to fixodent. She reported she called the company and they said to have her zinc level checked. The pt reports falling for no reason, no appetite, constipation, vomiting and gets sick the same time every evening. The pt reports that she had a stress test. (b)(6) pounds. Musculoskeletal exam: unsteady walks with cane. Blunted affect. Current medication: carbidopa-levodopa, prozac, hctz, loratadine, azilect, nexium, zofran, glipizide, zocor, asa. Plan to check zinc level. On (b)(6) 2011: zinc level drawn. On (b)(6) 2011: pt presents in office initially stating that she is here for f/u from a hospitalization for a heart attack. (b)(6) pounds. Review of records revealed that in early (b)(6) the pt had a heart attack, went through a catheterization and had multiple stents. The pt was not given a prescription for plavix, therefore; has not been taking it. On (b)(6) 2011: the pt with a past medical history of hyper tension, diabetes mellitus, cva (cerebrovascular accident) and an allergy to codeine, reports feeling ill two days ago, last night had severe pain running down left arm and also with some unusual pain in right side of jaw. (b)(6) pounds. Upon initial review; her symptoms were thought to be a stroke but after additional discussion today, believe it is a cardiac problem. Pt is concerned about chest pain and pain in left arm. Assessment: hypertension, long term medication therapy, diabetes mellitus, post cva hospitalization for heart attack, dysphasia, allergic rhinitis and diabetic medication reviewed. Refilled prescriptions for nitroglycerin and added prescription for plavix which the pt is not taking. Importance stressed to take hydrochlorothiazide as the pt has not been taking this medication. On (b)(6) 2011: pt reported going to emergency room on (b)(6) 2011 for vomiting. The pt reported that she had not been sleeping, feet and leg pain, hand tremor and spastic shakes. Musculoskeletal exam: analytical gait. No notable tremor with exam. Current medication: amlodipine, sinemet, prozac, hctz, phenergan, loratadine, plavix, azilect, nexium, zofran, glipizide, zocor. Plan: f/u with neurologist concerning tremors and myalgia complaints as well as nausea symptoms. Heart cath in (b)(6) and nausea started when placed on plavix. Advised pt to f/u with cardiologist concerning medication if cause of nausea symptoms. F/u next month or return sooner or go to emergency room for worsening symptoms. Assessment: nausea, vomiting, urinary tract infection, hyperlipidemia, status post parkinson disease.

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Type of DeviceNONE
Manufacturer (Section D)
brown summit NC
Manufacturer (Section G)
6200 bryan park rd.
brown summit NC 27214
Manufacturer Contact
8700 mason-montgomery rd.
mason business center
mason , OH 45040
MDR Report Key2509510
Report Number1530449-2012-00013
Device Sequence Number1
Product CodeKOO
Report Source Manufacturer
Source Type Health Professional
Type of Report Initial
Report Date 09/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2012
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Type of Device Usage Invalid Data

Date Received: 03/23/2012 Patient Sequence Number: 1