FDA.reportPublic FDA data

MAUDE MDR 6559690

MDR report key
6559690
Report number
1530449-2017-00002
Event key
0
Event type
3
Date received
2017-05-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MGR. REGULATORY ORAL CARE
Address
8700 MASON MONTGOMERY ROAD MASON OH 45040 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FIXODENT DENTURE ADHESIVE, CONTROL PLUS SCOPE FLAVORADHESIVE, DENTUREPROCTOR & GAMBLE MANUFACTURING CO.KOONOT AVAILABLER N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-1101. H; 2. O; 3. S

Event Narratives#

N

Patient 1

LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER AND CASE CONCERNS LONG-TERM PRODUCT USE.

D

Patient 1

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 FUR...