AMS AMBICOR PENILE PROSTHESIS 72401454

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-30 for AMS AMBICOR PENILE PROSTHESIS 72401454 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

• Report Number: 2183959-2019-67787
• MDR Report Key: 9392276
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-11-30
• Date of Report: 2019-11-30
• Date of Event: 2019-10-17
• Date Mfgr Received: 2019-11-05
• Device Manufacturer Date: 2017-09-12
• Date Added to Maude: 2019-11-30
• 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: ALYSON HARRIS
• Manufacturer Street: 10700 BREN ROAD W
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal: 55343
• Manufacturer Phone: 4089353452
• Manufacturer G1: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Street: 10700 BREN ROAD WEST
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal Code: 55343
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Generic Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Product Code: FHW
• Date Received: 2019-11-30
• Model Number: 72401454
• Catalog Number: 72401454
• Lot Number: 0181444005
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Address: 10700 BREN ROAD W MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-11-30