MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-10 for YOUNG DENTAL 214420 manufactured by Identa Dental Material Gmbh.
| Report Number | 1941138-2020-00001 |
| MDR Report Key | 9813573 |
| Report Source | CONSUMER |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-04 |
| Date Facility Aware | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE ESPINO |
| Manufacturer Street | 13705 SHORELINE COURT EAST |
| Manufacturer City | EARTH CITY, MO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YOUNG DENTAL |
| Generic Name | VARNISH, D-LISH, VANILLA CUPCAKE, 200CT, YD - EC, YOUNG |
| Product Code | LBH |
| Date Received | 2020-03-10 |
| Model Number | 214420 |
| Lot Number | 1826361 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IDENTA DENTAL MATERIAL GMBH |
| Manufacturer Address | ANTON-FLETTNER-STR. 3 CUXHAVEN, 27472 GM 27472 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |