AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES 9-PDA2AS-04-04-L

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 2019-08-09 for AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES 9-PDA2AS-04-04-L manufactured by Aga Medical Corporation.

MAUDE Entry Details

• Report Number: 2135147-2019-00227
• MDR Report Key: 8878816
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-08-09
• Date of Report: 2019-09-20
• Date of Event: 2019-07-22
• Date Mfgr Received: 2019-08-23
• Device Manufacturer Date: 2018-07-19
• Date Added to Maude: 2019-08-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: STEPHANIE O' SULLIVAN
• Manufacturer Street: 5050 NATHAN LANE NORTH
• Manufacturer City: PLYMOUTH MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer Phone: 6517565400
• Manufacturer G1: AGA MEDICAL CORPORATION
• Manufacturer Street: 5050 NATHAN LANE NORTH
• Manufacturer City: PLYMOUTH MN 55442
• Manufacturer Country: US
• Manufacturer Postal Code: 55442
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMPLATZER DUCT OCCLUDER II ADDITIONAL SIZES
• Generic Name: CARDIAC OCCLUSION DEVICE
• Product Code: MAE
• Date Received: 2019-08-09
• Model Number: 9-PDA2AS-04-04-L
• Catalog Number: 9-PDA2AS-04-04-L
• Lot Number: 6550762
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AGA MEDICAL CORPORATION
• Manufacturer Address: 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-09