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 2019-10-23 for ENDO ANCHOR SYSTEM - HELI-FX AAA SA-85 manufactured by Medtronic Ireland.
Report Number | 9612164-2019-04473 |
MDR Report Key | 9224264 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-10-23 |
Date of Report | 2019-10-23 |
Date of Event | 2019-08-29 |
Date Mfgr Received | 2019-10-16 |
Device Manufacturer Date | 2019-04-11 |
Date Added to Maude | 2019-10-23 |
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 | ALISON SWEENEY |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Manufacturer Phone | 091708096 |
Manufacturer G1 | MEDTRONIC IRELAND |
Manufacturer Street | PARKMORE BUSINESS PARK WEST |
Manufacturer City | GALWAY |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ENDO ANCHOR SYSTEM - HELI-FX AAA |
Generic Name | ENDOVASCULAR SUTURING SYSTEM |
Product Code | OTD |
Date Received | 2019-10-23 |
Model Number | SA-85 |
Catalog Number | SA-85 |
Lot Number | 0009690963 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC IRELAND |
Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-23 |