AMPLATZER DUCT OCCLUDER 9-PDA-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-12 for AMPLATZER DUCT OCCLUDER 9-PDA-004 manufactured by Aga Medical Corporation.

MAUDE Entry Details

Report Number2135147-2019-00194
MDR Report Key8784602
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-12
Date of Report2019-10-04
Date of Event2019-06-14
Date Mfgr Received2019-09-06
Device Manufacturer Date2019-05-06
Date Added to Maude2019-07-12
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1AGA MEDICAL CORPORATION
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPLATZER DUCT OCCLUDER
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
Product CodeMAE
Date Received2019-07-12
Model Number9-PDA-004
Catalog Number9-PDA-004
Lot Number6983935
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAGA MEDICAL CORPORATION
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-12

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