MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-29 for APTUS HELI-FX SA-85 manufactured by Medtronic Vascular.
Report Number | 9249407 |
MDR Report Key | 9249407 |
Date Received | 2019-10-29 |
Date of Report | 2019-10-21 |
Date of Event | 2019-10-18 |
Report Date | 2019-10-21 |
Date Reported to FDA | 2019-10-21 |
Date Reported to Mfgr | 2019-10-29 |
Date Added to Maude | 2019-10-29 |
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 | OTHER HEALTH CARE PROFESSIONAL |
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 | APTUS HELI-FX |
Generic Name | ENDOVASCULAR SUTURING SYSTEM |
Product Code | OTD |
Date Received | 2019-10-29 |
Model Number | SA-85 |
Catalog Number | SA-85 |
Lot Number | 0009714615 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC VASCULAR |
Manufacturer Address | 3850 BRICKWAY BLVD SANTA ROSA CA 95403 US 95403 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-29 |