PERCUFLEX PLUS M0061752530 175-253

MAUDE Adverse Event Report

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 2020-03-31 for PERCUFLEX PLUS M0061752530 175-253 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2020-01393
MDR Report Key9908300
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-06-06
Date Added to Maude2020-03-31
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2546 CALLE PRIMERA
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERCUFLEX PLUS
Generic NameCATHETER, BILIARY, DIAGNOSTIC
Product CodeFAD
Date Received2020-03-31
Model NumberM0061752530
Catalog Number175-253
Lot Number0023910260
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.