MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 manufactured by Agfa N.v..
| Report Number | 3001556265-2019-00008 |
| MDR Report Key | 8950160 |
| Date Received | 2019-08-30 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-08-19 |
| Date Mfgr Received | 2019-08-20 |
| Date Added to Maude | 2019-08-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CASSANDRA MCGOWAN |
| Manufacturer Street | 10 S ACADEMY ST |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211984 |
| Manufacturer G1 | AGFA N.V. |
| Manufacturer Street | SEPTESTRAAT 27 |
| Manufacturer City | MORTSEL, B2640 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B2640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 |
| Generic Name | DX-D 100 MOBILE |
| Product Code | IZL |
| Date Received | 2019-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA N.V. |
| Manufacturer Address | SEPTESTRAAT 27 MORTSEL, B2640 BE B2640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-30 |