CONTOUR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-11-12 for CONTOUR manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number2134265-2019-13656
MDR Report Key9310164
Report SourceCONSUMER,FOREIGN
Date Received2019-11-12
Date of Report2019-11-12
Date of Event2016-07-01
Date Mfgr Received2019-10-14
Date Added to Maude2019-11-12
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC LIMITED
Manufacturer StreetBUSINESS & TECHNOLOGY PARK MODEL FARM ROAD
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTOUR
Generic NameAGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
Product CodeNAJ
Date Received2019-11-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-12

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