MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2017-01-04 for FIXODENT ADHESIVE CREAM, VERSION UNKNOWN manufactured by Proctor & Gamble Manufacturing Co..
[63807904]
Return of product has been requested. Product and lot # not provided by the reporter, therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[63807905]
Sensory disturbance [sensory disturbance], leg weakness [muscular weakness], copper deficiency [copper deficiency], taking fixodent denture cream for dental cleaning/using excessive quantities of denture cream at increased dosage frequency [device use issue]. Case description: a pharmacist reported via a regulatory agency ((b)(6)) that a patient, age and gender unspecified, had used fixodent denture cream beginning (b)(6) 2011 through (b)(6) 2016, excessive quantities at an increased dosage frequency (four times daily), topically for dental cleaning, and was admitted to the hospital with sensory disturbance and leg weakness, which was felt likely secondary to copper deficiency. The copper deficiency was noted to have begun (b)(6) 2016. Product use was discontinued. Medication error details: patient using excessive quantities of denture cream at an increased dosage frequency. The patient was taking fixodent denture cream for: dental cleaning. Reporter comment: the other outcome for copper deficiency was: copper deficiency now being treated with an unlicensed oral supplement. Relevant history: other medication taken in the last 3 months-aspirin coated (ill-defined disorder), ramipril (ill-defined disorder), simvastatin (ill-defined disorder), folic acid (ill-defined disorder). According to the regulatory authority report, the reaction was considered to be serious and the reaction severity listed as "involved or prolonged inpatient hospitalization. " the case outcome was unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00001 |
| MDR Report Key | 6221053 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-16 |
| Date Mfgr Received | 2016-12-16 |
| Date Added to Maude | 2017-01-04 |
| 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 ADHESIVE CREAM, VERSION UNKNOWN |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-01-04 |
| 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 | 2017-01-04 |