MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-29 for DR 400 manufactured by Agfa-gevaert Healthcare Gmbh.
| Report Number | 9613152-2019-00001 |
| MDR Report Key | 8838948 |
| Date Received | 2019-07-29 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-07-29 |
| 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-GEVAERT HEALTHCARE GMBH |
| Manufacturer Street | MAX PLANCK STRASSE 1 |
| Manufacturer City | PEISSENBERG, D82380 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DR 400 |
| Generic Name | DR 400 |
| Product Code | MQB |
| Date Received | 2019-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA-GEVAERT HEALTHCARE GMBH |
| Manufacturer Address | MAX PLANCK STRASSE 1 PEISSENBERG, D82380 BE D82380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-29 |