NRG TRANSSEPTAL NEEDLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-11 for NRG TRANSSEPTAL NEEDLE manufactured by Baylis Medical Company Inc..

MAUDE Entry Details

Report Number9710452-2019-00025
MDR Report Key9182669
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-11
Date of Report2019-10-11
Date of Event2019-09-26
Date Mfgr Received2019-09-27
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 ContactDR. MEGHAL KHAKHAR
Manufacturer Street2775 MATHESON BLVD. EAST
Manufacturer CityMISSISSAUGA, ONTARIO L4W 4P7
Manufacturer CountryCA
Manufacturer PostalL4W 4P7
Manufacturer G1BAYLIS MEDICAL COMPANY INC.
Manufacturer Street2775 MATHESON BLVD. EAST
Manufacturer CityMISSISSAUGA, ONTARIO L4W 4P7
Manufacturer CountryCA
Manufacturer Postal CodeL4W 4P7
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNRG TRANSSEPTAL NEEDLE
Generic NameRF TRANSSEPTAL NEEDLE
Product CodeDXF
Date Received2019-10-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAYLIS MEDICAL COMPANY INC.
Manufacturer Address5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-11

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