FDA Adverse Event
Other
Summary report: N
EQUATE ANTIBACTERIAL DENTURE CLEANSER TABLETS
MDR report key: 2231578
·
Received August 24, 2011
Report
- Report Number
- 1219540-2011-00010
- Event Type
- Other
- Date Received
- August 24, 2011
- Date of Event
- August 13, 2011
- Report Date
- August 24, 2011
- 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 STATED THAT SHE DEVELOPED A SWOLLEN TONGUE AFTER USING THE PRODUCT FOR JUST ONE DAY. HER DOCTOR STATED SHE WAS HAVING AN ALLERGIC REACTION AND WAS GIVEN A STEROID SHOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EQUATE ANTIBACTERIAL DENTURE CLEANSER TABLETS | EFFERVESCENT DENTURE CLNR | EFT | TOWER LABORATORIES, LTD. | 10601-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |