WALLFLEX DUODENAL M00565020 6502

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 2019-10-11 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2019-04969
MDR Report Key9180217
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-11
Date of Report2019-10-10
Date of Event2019-09-13
Date Mfgr Received2019-09-19
Device Manufacturer Date2018-07-02
Date Added to Maude2019-10-11
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 StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLFLEX DUODENAL
Generic NameSTENT,METALLIC,EXPANDABLE,DUODENAL
Product CodeMUM
Date Received2019-10-11
Model NumberM00565020
Catalog Number6502
Lot Number0022324548
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
101. Required No Informationntervention 2019-10-11

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