MAUDE Adverse Event Report: AMS / BOSTON SCIENTIFIC CORPORATION INFLATABLE PENILE PROSTHESIS; PROSTHESIS, PENIS, INFLATABLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

Ams brand 3-piece penoscrotal inflatable penile prosthesis due to product malfunction.Unknown about serial number or lot number due to device being placed at another location, reportedly in (b)(6) 2017.Fda safety report id# (b)(4).

• Brand Name: INFLATABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMS / BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12086432
• MDR Text Key: 259156357
• Report Number: MW5102182
• Device Sequence Number: 1
• Product Code: JCW
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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