MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) PLC201400 manufactured by W.l. Gore & Associates.
Report Number | 2953161-2020-00009 |
MDR Report Key | 9889324 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2020-03-27 |
Date of Report | 2020-02-26 |
Date of Event | 2020-02-26 |
Device Manufacturer Date | 2015-10-21 |
Date Added to Maude | 2020-03-27 |
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 |
Manufacturer Contact | DOUGLAS RHODES |
Manufacturer Street | 1500 N. 4TH STREET |
Manufacturer City | AZ |
Manufacturer Phone | 9285263030 |
Manufacturer G1 | MEDICAL SUNNYVALE B/P |
Manufacturer Street | 1327 ORLEANS DRIVE |
Manufacturer City | SUNNYVALE CA 94089 |
Manufacturer Country | US |
Manufacturer Postal Code | 94089 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Product Code | MIH |
Date Received | 2020-03-27 |
Model Number | PLC201400 |
Catalog Number | PLC201400 |
Lot Number | 14398552 |
Device Expiration Date | 2018-09-30 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | W.L. GORE & ASSOCIATES |
Manufacturer Address | FLAGSTAFF AZ |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-27 |