MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-02-01 for FIXODENT DENTURE ADHESIVE COMPLETE manufactured by Procter & Gamble Manufacturing Co..
[37240833]
Return of product has been requested. Lot # provided by consumer. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[37240834]
Zinc toxicity [metal poisoning], neuropathy [neuropathy peripheral], numbness - legs [hypoaesthesia], tingling - legs [paraesthesia], lightheadedness [dizziness], shallow breathing [hypopnoea], uses too much fixodent, uses about one 2. 4 ounce tube a week [intentional device misuse]. Case description: a relative reported that the consumer, an elderly male, reported using fixodent denture adhesive complete original, beginning on an unknown date, and was confirmed to have zinc toxicity. The consumer stated that he had been using the original fixodent for several years, acknowledging that he had been using too much, about a 2. 4 ounce tube per week. On (b)(6) 2016 the consumer started to experience numbness and tingling in his legs, lightheadedness, and shallow breathing. The consumer called the relative, asking to call 911 on his behalf. The relative stated that the consumer was taken to the hospital, where he was admitted from (b)(6) 2016, and underwent several tests. The relative described how the hospital had been working with poison control to interpret the consumer's blood work. The consumer wore a heart monitor for 5 days and it was determined that his heart was fine. The doctors diagnosed the consumer with neuropathy, prescribed him gabapentin, and recommended that he follow up with a neurologist. He was discharged yesterday, (b)(6) 2016, and is home now. The relative stated that the consumer had not seen the neurologist yet, but about an hour ago today, (b)(6) 2016, the consumer put his dentures in and 'a light bulb went off that fixodent could be the cause of this. ' the consumer proceeded to take his dentures out, rinsed his mouth with anesthetic and brushed his remaining teeth. The case outcome was improved. No further information was provided. On (b)(6) 2016 consumer follow-up: the consumer reported that he was still recovering, and that while the fixodent denture adhesive complete original tube does say not to use more than one tube in two weeks, he confirmed that he used one tube per week, but he would not have thought 'it would cut it so close'. He stated that if the word 'neuropathy' was on the tube, that would have helped him so much. He reported that his recovery was going to take some time, and not just what he had gone through so far. The case outcome remained improved. No further information was provided. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2016-00001 |
| MDR Report Key | 5401910 |
| Report Source | CONSUMER |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-06 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-01-06 |
| Date Added to Maude | 2016-02-01 |
| 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 COMPLETE |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2016-02-01 |
| Lot Number | 52361707T1, T2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-02-01 |