N
Patient 1
PRODUCT WAS NOT PROVIDED BY THE REPORTER AND CASE CONCERNS LONG-TERM PRODUCT USE.
MAUDE MDR 5571351
- MDR report key
- 5571351
- Report number
- 1530449-2016-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-12
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FIXODENTDENTURECAREDENTUREADHESIVEFREECRM | ADHESIVE, DENTURE | PROCTOR & GAMBLE MANUFACTURING CO. | KOO | 2018 075210A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-12 | 0 | 1. O |
Event Narratives#
D
Patient 1
NUMBNESS FEET AND LEGS/ CANNOT FEEL FEET [HYPOAESTHESIA] NERVE PAIN LOWER BACK; NERVES ENDING ON MY BACK ARE SHARP [NEURALGIA] SLEEP A LOT [HYPERSOMNIA] NO BALANCE 2-3 YEARS [BALANCE DISORDER] CAN'T WALK WITHOUT CRUTCH [GAIT DISTURBANCE] USED 3-4 TUBES OF FIXODENT A WEEK; PLACE FIXODENT ALL AROUND THE PLATE NOT IN SECTIONS [INTENTIONAL DEVICE MISUSE] CASE DESCRIPTION: AN ELDERLY MALE CONSUMER REPORTED THAT HE HAD USED FIXODENT FOR 30 YEARS, 3-4 TUBES PER WEEK, AND FOR 3-4 YEARS HAS HAD NUMBNESS TO HIS FEET AND LEGS, CAN'T FEEL HIS FEET, NERVE PAIN TO HIS LOWER BACK STATING THE NERVES ENDING ON HIS BACK ARE SHARP, AND SLEEPS A LOT. HE HAS HAD NO BALANCE FOR 2-3 YEARS, AND REPORTED HE IS UNABLE TO WALK WITHOUT CRUTCHES. THE CONSUMER VISITED A DOCTOR WHO WAS UNABLE TO PROVIDE A DIAGNOSIS, AND REFERRED THE CONSUMER TO A HOSPITAL. THE CONSUMER REPORTED HE HAD USED FIXODENT DENTURE CARE DENTURE ADHESIVE ORIGINAL FOR YEARS, THEN FIXODENT DENTURE CARE DENTURE ADHESIVE FOOD SEAL, AND CURRENTLY USES FIXODENT DENTURE CARE DENTURE ADHESIVE FREE CREAM (NEUTRAL). HE REPORTED HIS DENTURE PLATES COME LOOSE WHEN HE EATS, AND HE HAS NOT SPOKEN TO A DENTIST. HE APPLIES THE PRODUCT ALL AROUND THE PLATE, AND NOT IN SECTIONS. THE CASE OUTCOME WAS NOT RECOVERED/ NOT RESOLVED. RELEVANT HISTORY: - ALLERGY/INTOLERANCE: NONE. CONCOMITANT PRODUCT(S): NIMODIPINE; ASPIRIN CHLO; FURESOMIDE; LYRICA; PARACETAMOL; CEFUROXIME; TRAMADOL. (B)(6) 2016 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED HE WAS STILL TAKING ALL HIS MEDICATIONS, AND ALL HIS SYMPTOMS CONTINUED TO BE PRESENT. HE VISITED A DOCTOR ON (B)(6) 2016, AND HAD A ZINC TEST. RESULTS OF THE TEST WERE NOT YET AVAILABLE. THE CONSUMER INQUIRED ABOUT A STRONGER PRODUCT TO HOLD HIS DENTURES, AND EXPLAINED THAT HE NEEDS NEW DENTURES. THE CASE OUTCOME REMAINED NOT RECOVERED/ NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.
N
Patient 1
PRODUCT WAS NOT PROVIDED BY THE REPORTER AND CASE CONCERNS LONG-TERM PRODUCT USE.
D
Patient 1
NUMBNESS FEET AND LEGS/ CANNOT FEEL FEET [HYPOAESTHESIA] NERVE PAIN LOWER BACK; NERVES ENDING ON MY BACK ARE SHARP [NEURALGIA] SLEEP A LOT [HYPERSOMNIA] NO BALANCE 2-3 YEARS [BALANCE DISORDER] CAN'T WALK WITHOUT CRUTCH [GAIT DISTURBANCE] USED 3-4 TUBES OF FIXODENT A WEEK; PLACE FIXODENT ALL AROUND THE PLATE NOT IN SECTIONS [INTENTIONAL DEVICE MISUSE] PLATES COMING LOOSE WHEN I EAT - FIXODENT [DEVICE INEFFECTIVE] CASE DESCRIPTION: AN ELDERLY MALE CONSUMER REPORTED THAT HE HAD USED FIXODENT FOR 30 YEARS, 3-4 TUBES PER WEEK, AND FOR 3-4 YEARS HAS HAD NUMBNESS TO HIS FEET AND LEGS, CAN'T FEEL HIS FEET, NERVE PAIN TO HIS LOWER BACK STATING THE NERVES ENDING ON HIS BACK ARE SHARP, AND SLEEPS A LOT. HE HAS HAD NO BALANCE FOR 2-3 YEARS, AND REPORTED HE IS UNABLE TO WALK WITHOUT CRUTCHES. THE CONSUMER VISITED A DOCTOR WHO WAS UNABLE TO PROVIDE A DIAGNOSIS, AND REFERRED THE CONSUMER TO A HOSPITAL. THE CONSUMER REPORTED HE HAD USED FIXODENT DENTURE CARE DENTURE ADHESIVE ORIGINAL FOR YEARS, THEN FIXODENT DENTURE CARE DENTURE ADHESIVE FOOD SEAL, AND CURRENTLY USES FIXODENT DENTURE CARE DENTURE ADHESIVE FREE CREAM (NEUTRAL). HE REPORTED HIS DENTURE PLATES COME LOOSE WHEN HE EATS, AND HE HAS NOT SPOKEN TO A DENTIST. HE APPLIES THE PRODUCT ALL AROUND THE PLATE, AND NOT IN SECTIONS. THE CASE OUTCOME WAS NOT RECOVERED/ NOT RESOLVED. RELEVANT HISTORY: - ALLERGY/INTOLERANCE: NONE. CONCOMITANT PRODUCT(S): NIMODIPINE; ASPIRIN CHLO; FURESOMIDE; LYRICA; PARACETAMOL; CEFUROXIME; TRAMODOL. ON 31-MAR-2016 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED HE WAS STILL TAKING ALL HIS MEDICATIONS, AND ALL HIS SYMPTOMS CONTINUED TO BE PRESENT. HE VISITED A DOCTOR ON (B)(6) 2016, AND HAD A ZINC TEST. RESULTS OF THE TEST WERE NOT YET AVAILABLE. THE CONSUMER INQUIRED ABOUT A STRONGER PRODUCT TO HOLD HIS DENTURES, AND EXPLAINED THAT HE NEEDS NEW DENTURES. THE CASE OUTCOME REMAINED NOT RECOVERED/ NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON 25-APR-2016 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THE TEST RESULT WAS NEGATIVE FOR ZINC, AND HE WAS TOLD "EVERYTHING WAS OK." NO FURTHER INFORMATION WAS PROVIDED.
N
Patient 1
PRODUCT WAS NOT PROVIDED BY THE REPORTER AND CASE CONCERNS LONG-TERM PRODUCT USE.
D
Patient 1
NUMBNESS FEET AND LEGS/ CANNOT FEEL FEET [HYPOAESTHESIA]; NERVE PAIN LOWER BACK; NERVES ENDING ON MY BACK ARE SHARP [NEURALGIA]; SLEEP A LOT [HYPERSOMNIA]; NO BALANCE 2-3 YEARS [BALANCE DISORDER]; CAN'T WALK WITHOUT CRUTCH [GAIT DISTURBANCE]; USED 3-4 TUBES OF FIXODENT A WEEK; PLACE FIXODENT ALL AROUND THE PLATE NOT IN SECTIONS [INTENTIONAL DEVICE MISUSE]; PLATES COMING LOOSE WHEN I EAT - FIXODENT [DEVICE INEFFECTIVE]; AXONAL PERIPHERAL NEUROPATHY [AXONAL NEUROPATHY]. CASE DESCRIPTION: AN ELDERLY MALE CONSUMER REPORTED THAT HE HAD USED FIXODENT FOR 30 YEARS, 3-4 TUBES PER WEEK, AND FOR 3-4 YEARS HAS HAD NUMBNESS TO HIS FEET AND LEGS, CAN'T FEEL HIS FEET, NERVE PAIN TO HIS LOWER BACK STATING THE NERVES ENDING ON HIS BACK ARE SHARP, AND SLEEPS A LOT. HE HAS HAD NO BALANCE FOR 2-3 YEARS, AND REPORTED HE IS UNABLE TO WALK WITHOUT CRUTCHES. THE CONSUMER VISITED A DOCTOR WHO WAS UNABLE TO PROVIDE A DIAGNOSIS, AND REFERRED THE CONSUMER TO A HOSPITAL. THE CONSUMER REPORTED HE HAD USED FIXODENT DENTURE CARE DENTURE ADHESIVE ORIGINAL FOR YEARS, THEN FIXODENT DENTURE CARE DENTURE ADHESIVE FOOD SEAL, AND CURRENTLY USES FIXODENT DENTURE CARE DENTURE ADHESIVE FREE CREAM (NEUTRAL). HE REPORTED HIS DENTURE PLATES COME LOOSE WHEN HE EATS, AND HE HAS NOT SPOKEN TO A DENTIST. HE APPLIES THE PRODUCT ALL AROUND THE PLATE, AND NOT IN SECTIONS. THE CASE OUTCOME WAS NOT RECOVERED/ NOT RESOLVED. RELEVANT HISTORY: - ALLERGY/INTOLERANCE: NONE. CONCOMITANT PRODUCT(S): NIMODIPINE; ASPIRIN CHLO; FURESOMIDE; LYRICA; PARACETAMOL; CEFUROXIME; TRAMODOL. ON 31-MAR-2016 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED HE WAS STILL TAKING ALL HIS MEDICATIONS, AND ALL HIS SYMPTOMS CONTINUED TO BE PRESENT. HE VISITED A DOCTOR ON (B)(6) 2016, AND HAD A ZINC TEST. RESULTS OF THE TEST WERE NOT YET AVAILABLE. THE CONSUMER INQUIRED ABOUT A STRONGER PRODUCT TO HOLD HIS DENTURES, AND EXPLAINED THAT HE NEEDS NEW DENTURES. THE CASE OUTCOME REMAINED NOT RECOVERED/ NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON 25-APR-2016 RECEIVED CONSUMER FOLLOW-UP: THE CONSUMER REPORTED THE TEST RESULT WAS NEGATIVE FOR ZINC, AND HE WAS TOLD "EVERYTHING WAS OK." NO FURTHER INFORMATION WAS PROVIDED. ON 23-JUN-2016 RECEIVED CONSUMER'S MEDICAL QUESTIONNAIRE COMPLETED ON (B)(6) 2016: THE CONSUMER, CURRENT AGE (B)(6), REPORTED THE FULL NAME OF THE PRODUCT WAS FIXODENT NEUTRAL. HE REPORTED HE HAD BEEN USING FIXODENT FOR YEARS, 3 TUBES PER WEEK FOR 20-30 YEARS BEGINNING APPROXIMATELY IN (B)(6) 1990, AND HAD EXPERIENCED PROBLEMS BEGINNING ON AN UNSPECIFIED DATE AND LASTING FOR MONTHS. HE STATED A FRIEND TOLD HIM THAT ZINC IS HARMFUL. THE CONSUMER REPORTED HE HAD BEEN EXPERIENCING PROBLEMS WITH HIS NERVE ENDINGS AT THE BOTTOM OF HIS SPINE, BUT TESTS AT THE HOSPITAL DETERMINED IT WAS NOT CAUSED BY THE FIXODENT. THE CONSUMER HAD SEEN A CONSULTANT NEUROLOGIST, AND HAD ALSO CONSULTED A PHARMACIST OR OTHER HEALTHCARE PROFESSIONAL. NO TREATMENT WAS PRESCRIBED. THE CONSUMER DISCONTINUED USE OF FIXODENT ON (B)(6) 2016, AND HIS SYMPTOMS WERE STILL PRESENT. THE CASE OUTCOME REMAINED NOT RECOVERED/ NOT RESOLVED. RELEVANT HISTORY: THE CONSUMER REPORTED HE HAD CONFIRMED ALLERGIES WHICH WERE NOT SPECIFIED, BUT HE DID NOT HAVE A HISTORY OF ASTHMA, HAY FEVER, OR ECZEMA. THE CONSUMER INDICATED THE MEDICAL PROBLEM FOR WHICH HE BEGAN USING THE PRODUCT WAS WORSE. WHEN ASKED TO DESCRIBE ANY OTHER MEDICAL CONDITIONS EXPERIENCED DURING THE PAST 6 MONTHS, THE CONSUMER STATED HE HAD SLOWLY PROGRESSIVE AXONAL PERIPHERAL NEUROPATHY WHICH WAS BEING TREATED WITH SUPPORTIVE CARE. HE CONTINUED TO TAKE UNSPECIFIED MEDICATION. NO FURTHER INFORMATION WAS PROVIDED.