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 |