MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for DORNIER OPUS II K1025692 manufactured by Dornier Medtech Systems Gmbh.
| Report Number | 1037955-2016-00046 |
| MDR Report Key | 6200778 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-01 |
| Date Facility Aware | 2016-12-01 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2012-08-31 |
| Date Added to Maude | 2016-12-22 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER JENKINS |
| Manufacturer Street | 1155 ROBERTS BLVD. SUITE 100 |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146123 |
| Manufacturer G1 | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Street | ARGELSRIEDER FELD 7 |
| Manufacturer City | WESSLING, BAVARIA D-82234 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-82234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DORNIER OPUS II |
| Generic Name | TABLE |
| Product Code | KQS |
| Date Received | 2016-12-22 |
| Model Number | OPUS II |
| Catalog Number | K1025692 |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING, BAVARIA D-82234 GM D-82234 |