THORACIC CATHETER REF # 8132

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for THORACIC CATHETER REF # 8132 manufactured by Atrium Medical Corporation.

MAUDE Entry Details

Report NumberMW5090324
MDR Report Key9174685
Date Received2019-10-09
Date of Report2019-10-08
Date of Event2019-09-18
Date Added to Maude2019-10-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTHORACIC CATHETER
Generic NameCATHETER, CHOLANGIOGRAPHY
Product CodeGBZ
Date Received2019-10-09
Catalog NumberREF # 8132
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer AddressHUDSON NH 03051 US 03051


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-09

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