CAPIO SLIM SYSTEM 831826

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-28 for CAPIO SLIM SYSTEM 831826 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number8939691
MDR Report Key8939691
Date Received2019-08-28
Date of Report2019-07-16
Date of Event2019-07-08
Report Date2019-07-23
Date Reported to FDA2019-07-23
Date Reported to Mfgr2019-08-28
Date Added to Maude2019-08-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPIO SLIM SYSTEM
Generic NameBOSTON SCIENTIFIC CAPIO SLIM SYSTEM
Product CodePWI
Date Received2019-08-28
Model Number831826
Catalog Number831826
Lot Number22872708
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-28

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