MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-19 for FIXODENT NI manufactured by The Procter & Gamble Co..
[18950279]
A consumer reported that she developed loose stools after using fixodent denture adhesive. She stated that she has used this product many times and initially didn't think her reaction had anything to do with the product and used it again. She claims that she got very ill (fever, gastrointestinal symptoms) and it took several days to resolve. She states that she noticed the product looked somewhat gray in color. She purchased it on 12/26/98.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002408 |
| MDR Report Key | 207574 |
| Date Received | 1999-01-19 |
| Date of Report | 1999-01-19 |
| Date Added to Maude | 1999-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENT |
| Generic Name | DENTURE CLEANSER |
| Product Code | KOP |
| Date Received | 1999-01-19 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 3161012 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201478 |
| Manufacturer | THE PROCTER & GAMBLE CO. |
| Manufacturer Address | 1 PROCTER & GAMBLE PLAZA CINCINNATI OH 45202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-01-19 |