SENSOR M0066703061 670-306

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 2019-10-29 for SENSOR M0066703061 670-306 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number3005099803-2019-05313
MDR Report Key9252369
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-29
Date of Report2019-11-26
Date of Event2019-09-01
Date Mfgr Received2019-11-01
Device Manufacturer Date2017-12-07
Date Added to Maude2019-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameSENSOR
Generic NameSTYLET FOR CATHETER, GASTRO-UROLOGY
Product CodeEZB
Date Received2019-10-29
Returned To Mfg2019-10-10
Model NumberM0066703061
Catalog Number670-306
Lot Number0021480788
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2019-10-29

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