EXPRESS SD RENAL/BILIARY 20188

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-16 for EXPRESS SD RENAL/BILIARY 20188 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number2134265-2019-12457
MDR Report Key9198747
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-16
Date of Report2019-11-18
Date of Event2019-09-30
Date Mfgr Received2019-11-04
Device Manufacturer Date2018-07-10
Date Added to Maude2019-10-16
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXPRESS SD RENAL/BILIARY
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeNIN
Date Received2019-10-16
Returned To Mfg2019-10-16
Model Number20188
Catalog Number20188
Lot Number0022354965
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-16

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