MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for ANGIOJET ULTRA POWER PULSE U3775 manufactured by Boston Scientific Corporation.
Report Number | 9391804 |
MDR Report Key | 9391804 |
Date Received | 2019-11-29 |
Date of Report | 2019-11-19 |
Date of Event | 2019-10-31 |
Report Date | 2019-11-19 |
Date Reported to FDA | 2019-11-19 |
Date Reported to Mfgr | 2019-11-29 |
Date Added to Maude | 2019-11-29 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
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 | ANGIOJET ULTRA POWER PULSE |
Generic Name | CATHETER, CONTINUOUS FLUSH |
Product Code | KRA |
Date Received | 2019-11-29 |
Model Number | U3775 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-29 |