FDA Adverse Event
Summary report: N
DG HEALTH EFFERVESCENT OVERNIGHT DENTURE CLEANSER TABLETS
MDR report key: 3913884
·
Received July 3, 2014
Report
- Report Number
- 1219540-2014-00004
- Date Received
- July 3, 2014
- Date of Event
- June 11, 2014
- Report Date
- July 3, 2014
- Manufacturer
- TOWER LABORATORIES LTD
- Product Code
- EFT
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER PURCHASED THE DG HEALTH OVERNIGHT DENTURE CLEANSER AND AFTER USING THE PRODUCT, DEVELOPED BLISTERS IN HER MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390257 | DG HEALTH EFFERVESCENT OVERNIGHT DENTURE CLEANSER TABLETS | EFFERVESCENT DENTURE CLEANSER TABLETS | EFT | TOWER LABORATORIES LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |