MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for AGILITY 67000 manufactured by Dynex Technologies.
| Report Number | 1117676-2019-00001 |
| MDR Report Key | 8623089 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-07-24 |
| Date Added to Maude | 2019-05-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CANDICE PROWSE |
| Manufacturer Street | 14340 SULLYFIELD CIRCLE |
| Manufacturer City | CHANTILLY VA 201511621 |
| Manufacturer Country | US |
| Manufacturer Postal | 201511621 |
| Manufacturer Phone | 7038031218 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AGILITY |
| Generic Name | AUTOMATED ELISA SYSTEM |
| Product Code | JJQ |
| Date Received | 2019-05-20 |
| Model Number | AGILITY |
| Catalog Number | 67000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNEX TECHNOLOGIES |
| Manufacturer Address | 14340 SULLYFIELD CIRCLE CHANTILLY VA 201511621 US 201511621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |