MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-17 for ULRICHINJECT CT MOTION PEDESTAL VERSION XD 8000-001 manufactured by Ulrich Gmbh & Co. Kg.
| Report Number | 9612420-2019-00050 |
| MDR Report Key | 9075247 |
| Date Received | 2019-09-17 |
| Date of Report | 2019-09-16 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-06-07 |
| Date Added to Maude | 2019-09-17 |
| 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 | MR. CHRISTOPH ULRICH |
| Manufacturer Street | BUCHBRUNNENWEG 12 NA |
| Manufacturer City | ULM, BADEN-W 89081 |
| Manufacturer Country | GM |
| Manufacturer Postal | 89081 |
| Manufacturer G1 | ULRICH GMBH & CO. KG |
| Manufacturer Street | BUCHBRUNNENWEG 12 NA |
| Manufacturer City | ULM, 89081 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 89081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULRICHINJECT CT MOTION PEDESTAL VERSION |
| Generic Name | ULRICHINJECT CT MOTION PEDESTAL VERSION |
| Product Code | IZQ |
| Date Received | 2019-09-17 |
| Model Number | XD 8000-001 |
| Catalog Number | XD 8000-001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULRICH GMBH & CO. KG |
| Manufacturer Address | BUCHBRUNNENWEG 12 NA ULM, 89081 GM 89081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-17 |