CRE WIREGUIDED M00558480 5848

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 2020-03-17 for CRE WIREGUIDED M00558480 5848 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2020-00867
MDR Report Key9844891
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-12-13
Date Mfgr Received2020-02-19
Device Manufacturer Date2018-06-25
Date Added to Maude2020-03-17
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 CORK LIMITED
Manufacturer StreetCORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRE WIREGUIDED
Generic NameDILATOR, ESOPHAGEAL
Product CodeKNQ
Date Received2020-03-17
Returned To Mfg2020-01-20
Model NumberM00558480
Catalog Number5848
Lot Number0022294354
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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