MAUDE Adverse Event Report: UNKNOWN PROSTHESIS, PENIS, INFLATABLE

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that this inflatable penile prosthesis was explanted and replaced due to an unspecified reason.No patient complications were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROSTHESIS, PENIS, INFLATABLE
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18021729
• MDR Text Key: 326903705
• Report Number: MW5147352
• 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: Other
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention