MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEM, INC. PROSTHESIS, PENIS, INFLATABLE

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 10/10/2019

Event Type  malfunction  

Event Description

The pt who had a 3 pieces inflatable penile prosthesis placed for erectile dysfunction and the device malfunctioned and lost fluid.Device was 18 cm with 4 cm of rear tip extension.The pt underwent complete exchange of inflatable penile prosthesis.A tear in the proximal left corporal cylinder was noted in the old implant.

• Brand Name: PROSTHESIS, PENIS, INFLATABLE
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEM, INC.
• MDR Report Key: 9224989
• MDR Text Key: 163631491
• Report Number: MW5090569
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• 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 Age: 65 YR
• Patient Weight: 87