AMPLATZER DUCT OCCLUDER 9-PDA-005

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 2019-08-19 for AMPLATZER DUCT OCCLUDER 9-PDA-005 manufactured by Aga Medical Corporation.

MAUDE Entry Details

Report Number2135147-2019-00249
MDR Report Key8906285
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-19
Date of Report2019-10-03
Date of Event2019-07-24
Date Mfgr Received2019-09-13
Device Manufacturer Date2018-07-11
Date Added to Maude2019-08-19
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 ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
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 Received2019-08-19
Model Number9-PDA-005
Catalog Number9-PDA-005
Lot Number6537373
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
101. Hospitalization; 2. Required No Informationntervention 2019-08-19

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