MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-25 for D-LISH VARNISH 214450 manufactured by Young Dental Manufacturing Co., Llc.
[52939884]
It was confirmed that the product did not contain any of the items that the patient was reported to be allergic to. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[52939945]
Patient experienced symptoms of burning around the mouth. No medical intervention was necessary and symptoms subsided on their own within a short time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00014 |
| MDR Report Key | 5903032 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-08-04 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-08-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE CT. E |
| Manufacturer City | EARTH CITY MO 32045 |
| Manufacturer Country | US |
| Manufacturer Postal | 32045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-LISH VARNISH |
| Generic Name | VARNISH |
| Product Code | LBH |
| Date Received | 2016-08-25 |
| Model Number | 214450 |
| Catalog Number | 214450 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING CO., LLC |
| Manufacturer Address | 13705 SHORELINE CT. E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-25 |