MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for FIXODENT CONTROL * manufactured by *.
[15445133]
Pt never used any product before on their dentures. Upon visiting dentist for a routine checkup dentist provided them with a tube (no charge) of fixodent control denture adhesive cream. Pt did not use this product until 4 days later at about 12 noon. Pt awoke at about 4 am the next day, with a feeling that their heart "was racing" and had hives on arms. They called 911, and were taken to hospital, where they were released 4 or 5 hours later. Pt has not returned to using this product; and has no new adverse events to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003864 |
| MDR Report Key | 570519 |
| Date Received | 2005-02-02 |
| Date of Report | 2004-10-22 |
| Date of Event | 2004-10-18 |
| Date Added to Maude | 2005-02-08 |
| 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 | 3 |
| 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 CONTROL |
| Generic Name | DENTURE ADHESIVE CREAM |
| Product Code | KOQ |
| Date Received | 2005-02-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | T3368/95216424 |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 560367 |
| Manufacturer | * |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-02 |