MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-19 for FIXODENT manufactured by Proctor And Gamble.
[189489]
A dried up dark colored substance resembling a bug came out of the tube. The object measures approx 1/16" l.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002986 |
| MDR Report Key | 328546 |
| Date Received | 2001-04-19 |
| Date of Report | 2001-03-13 |
| Date of Event | 2000-12-01 |
| Date Added to Maude | 2001-04-26 |
| 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 ADHESIVE |
| Product Code | KOM |
| Date Received | 2001-04-19 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | 0174GT2 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 317939 |
| Manufacturer | PROCTOR AND GAMBLE |
| Manufacturer Address | 100 SWING RD GREENSBORO NC 27409 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-19 |