MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-30 for AXIOS STENT AND DELIVERY SYSTEM M00553550 5355 manufactured by Boston Scientific Corporation.
Report Number | 3005099803-2020-00208 |
MDR Report Key | 9646865 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-01-30 |
Date of Report | 2020-01-31 |
Date of Event | 2020-01-10 |
Date Mfgr Received | 2020-01-10 |
Device Manufacturer Date | 2019-10-16 |
Date Added to Maude | 2020-01-30 |
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 |
Manufacturer Contact | CAROLE MORLEY |
Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
Manufacturer City | MARLBOROUGH MA 01752 |
Manufacturer Country | US |
Manufacturer Postal | 01752 |
Manufacturer Phone | 5086834015 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | BALLYBRIT BUSINESS PARK |
Manufacturer City | GALWAY |
Manufacturer Country | EI |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AXIOS STENT AND DELIVERY SYSTEM |
Generic Name | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE |
Product Code | PCU |
Date Received | 2020-01-30 |
Model Number | M00553550 |
Catalog Number | 5355 |
Lot Number | 0024603768 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-30 |