MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER manufactured by Gsk Consumer Healthcare Holdings (us) Llc.
[180610999]
Since october had been using polident 4 min daily cleanser as directed on a dental device, i wear at night as recommended by my dental office. Experienced burning sensation on my tongue and tongue bleeding for several weeks. Symptoms resolved after discontinuing use of polident for cleaning. I used polident again once to clean my device and experienced same symptoms after one night of wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093129 |
| MDR Report Key | 9733559 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-16 |
| Date Added to Maude | 2020-02-20 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER |
| Generic Name | CLEANSER, DENTURE, OVER THE COUNTER |
| Product Code | EFT |
| Date Received | 2020-02-19 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GSK CONSUMER HEALTHCARE HOLDINGS (US) LLC |
| Product Code | --- |
| Date Received | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |