FDA Adverse Event
Other
Summary report: N
EQUATE DOUBLE ACTION DENTURE CLEANSER
MDR report key: 2974240
·
Received February 13, 2013
Report
- Report Number
- 1219540-2013-00001
- Event Type
- Other
- Date Received
- February 13, 2013
- Date of Event
- February 10, 2013
- Report Date
- February 13, 2013
- Manufacturer
- TOWER LABORATORIES, LTD.
- Product Code
- EFT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CONSUMER REPORTED HAVING USED THE EQUATE DOUBLE ACTION DENTURE CLEANSER FOR APPROXIMATELY 6 DAYS TO CLEAN HER DENTURES. CONSUMER REPORTS THAT THE DENTURE CLEANSER CAUSED HER GUMS TO BECOME SORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64411 | EQUATE DOUBLE ACTION DENTURE CLEANSER | EFFERVESCENT DENTURE CLNR | EFT | TOWER LABORATORIES, LTD. | 21133-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |