MAUDE Adverse Event Report: BOSTON SCIENTIFIC AMS AMBICOR PENILE PROSTHESIS

Model Number 72401451

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2018

Event Type  malfunction  

Event Description

Penile implant placed (b)(6) 2016, device was explanted on (b)(6) 2018 due to mechanical complication of prosthetic device.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Type of Device: AMS AMBICOR PENILE PROSTHESIS
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7250950
• MDR Text Key: 99607023
• Report Number: MW5075116
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2021
• Device Model Number: 72401451
• Device Lot Number: 120453005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 106