MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 CX PENILE PUMP; PROSTHESIS, PENILE

Lot Number 1000227024

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/23/2019

Event Type  Injury  

Event Description

Ams penile pump was implanted by surgeon and discovered to be malfunctioned.It was then removed.Treated start/stop date: (b)(6) 2019.Is therapy still on-going? no.Fda safety report id# (b)(4).

• Brand Name: AMS 700 CX PENILE PUMP
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 8582328
• MDR Text Key: 144238123
• Report Number: MW5086376
• Device Sequence Number: 1
• Product Code: FAE
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1000227024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2019
• 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): Required Intervention