MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-23 for GX-770 0.820.0146 manufactured by Gendex Dental Systems.
| Report Number | 2530069-2019-00006 |
| MDR Report Key | 9226657 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-23 |
| Date of Report | 2019-10-23 |
| Date of Event | 2019-05-14 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 1989-01-01 |
| Date Added to Maude | 2019-10-23 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AL MYERS |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2159975665 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX-770 |
| Generic Name | UNIT, X-RAY EXTRAORAL WITH TIMER |
| Product Code | EHD |
| Date Received | 2019-10-23 |
| Model Number | GX-770 |
| Catalog Number | 0.820.0146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-23 |