EKOSONIC ENDOVASCULAR CATHETER 500-55112

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-21 for EKOSONIC ENDOVASCULAR CATHETER 500-55112 manufactured by Ekos Corporation.

MAUDE Entry Details

Report Number3001627457-2020-00006
MDR Report Key9741591
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-21
Date of Report2020-02-04
Date of Event2020-02-03
Date Mfgr Received2020-02-04
Device Manufacturer Date2019-10-24
Date Added to Maude2020-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SANDARA BAUSBACK-ABALLO
Manufacturer Street300 CONSHOHOCKEN STATE RD, 300 FOUR FALLS CORPORATE CTR.
Manufacturer CityWEST CONSHOHOCKEN, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1EKOS CORPORATION
Manufacturer Street11911 NORTH CREEK PARKWAY
Manufacturer CityBOTHELL, WA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEKOSONIC ENDOVASCULAR CATHETER
Generic NameEKOSONIC ENDOVASCULAR CATHETER
Product CodeKRA
Date Received2020-02-21
Returned To Mfg2020-02-14
Model Number500-55112
Catalog Number500-55112
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerEKOS CORPORATION
Manufacturer Address11911 NORTH CREEK PARKWAY S BOTHELL, WA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.