MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-23 for FIXODENT ADHESIVE ORIGINAL CREAM, NO FLAVOR manufactured by Proctor & Gamble Manufacturing Co..
[48048569]
Product was not provided by the reporter and case concerns long-term product use.
Patient Sequence No: 1, Text Type: N, H10
[48048570]
Nerve damage [nerve injury]. Numbness - feet, hands [hypoaesthesia]. Tingling - feet, hands [paraesthesia]. Nerve pain - feet, hands, legs [neuralgia]. Never measured but use it 1-2 times a day- fixodent [device use issue]. Neuropathy [neuropathy peripheral]. Spinalitis [spinal disorder]. Case description: (b)(6) year old female consumer reported she has used fixodent denture care denture adhesive original cream no flavor-scent 2. 4oz, and fixodent denture care denture adhesive, for a long time to hold her dentures, and she had nerve damage. For the past 5 or 6 years, she has had numbness and tingling to both hands and feet, and nerve pain to her feet, hands, and down her legs. She stated she also uses "the term neuropathy and spinalitis for it too. " she stated she saw on the internet that the zinc in fixodent causes everything she had. She reported she never measured the amount of the product she used, but she used it 1 to 2 times a day. She reported she has seen doctors, a neurologist, pain specialists, and an orthopedic doctor, and has had mri's and x-rays. She has received treatments of epidural shots in her spine, and another type of unspecified injection in her spine. She has had a wire inserted in her back, and electric shock patches on her back. She stated she may have also used some creams topically as treatment. The consumer reported she did not know if she used the same fixodent every time, and she has sometimes used a store brand product. The consumer reported she had no allergies, and described herself as a "cripple stuck in a wheel chair. " the case outcome was not recovered/not resolved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[56562308]
On 23-sep-2016 product investigation results: manufactured as intended based on investigation.
Patient Sequence No: 1, Text Type: N, H10
[56562309]
Nerve damage [nerve injury]. Numbness - feet, hands [hypoaesthesia]. Tingling - feet, hands [paraesthesia]. Nerve pain - feet, hands, legs [neuralgia]. Never measured but use it 1-2 times a day- fixodent [device use issue]. Neuropathy [neuropathy peripheral]. Spinalitis [spinal disorder]. Case description: an (b)(6) female consumer reported she has used fixodent denture care denture adhesive original cream no flavor-scent 2. 4oz, and fixodent denture care denture adhesive, for a long time to hold her dentures, and she had nerve damage. For the past 5 or 6 years she has had numbness and tingling to both hands and feet, and nerve pain to her feet, hands, and down her legs. She stated she also uses "the term neuropathy and spinalitis for it too. " she stated she saw on the internet that the zinc in fixodent causes everything she had. She reported she never measured the amount of the product she used, but she used it 1 to 2 times a day. She reported she has seen doctors, a neurologist, pain specialists, and an orthopedic doctor, and has had mri's and x-rays. She has received treatments of epidural shots in her spine, and another type of unspecified injection in her spine. She has had a wire inserted in her back, and electric shock patches on her back. She stated she may have also used some creams topically as treatment. The consumer reported she did not know if she used the same fixodent every time, and she has sometimes used a store brand product. The consumer reported she had no allergies, and described herself as a "cripple stuck in a wheel chair. " the case outcome was not recovered/not resolved. No further information was provided. On 23-sep-2016 product investigation results: the consumer did not return the product. Batch manufacturing check finds: no other complaints were noted on the daycode in question. No problems were reported during making or packing. Each of the 15 bulk batches passed analytical testing, including texture/appearance, odor, viscosity and ph tests with no issues noted. No defects were noted during hourly appearance inspections. Each of these inspections includes a smear test to check product texture & appearance and to verify the absence of foreign matter. Finished product testing including appearance and odor passed. Making and lab records indicate that product was made in accordance with established specifications, with no indication of mis-formulation. There were no alerts or deviations found that could have contributed to the defect reported. Conclusion: manufactured as intended based on investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2016-00007 |
| MDR Report Key | 5745377 |
| Report Source | CONSUMER |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-07 |
| Date Mfgr Received | 2016-09-23 |
| Date Added to Maude | 2016-06-23 |
| 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 ORIGINAL CREAM, NO FLAVOR |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2016-06-23 |
| Lot Number | 53351707T1 |
| ID Number | NOT AVAILABLE |
| Device Expiration Date | 2018-11-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2016-06-23 |