MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-27 for TUMARK VISION 271590 manufactured by Somatex Medical Technologies Gmbh.
| Report Number | 1000408433-2019-00001 |
| MDR Report Key | 9380836 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-08-16 |
| Date Facility Aware | 2019-08-22 |
| Report Date | 2019-08-22 |
| Date Reported to Mfgr | 2019-08-22 |
| Date Mfgr Received | 2019-08-22 |
| Date Added to Maude | 2019-11-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUMARK VISION |
| Generic Name | TUMARK VISION |
| Product Code | NEU |
| Date Received | 2019-11-27 |
| Model Number | 271590 |
| Catalog Number | 271590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATEX MEDICAL TECHNOLOGIES GMBH |
| Manufacturer Address | HOHENZOLLERNDAMM 150/151 BERLIN, 14199 GM 14199 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-11-27 |