MAUDE Adverse Event Report: PROSTHESIS, PENIS, INFLATABLE

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 05/09/2023

Event Type  Injury  

Event Description

It was reported that the patient with an inflatable penile prosthesis (ipp) presented with an infection.The patient underwent surgical intervention to explant the-device and replace with a malleable penile prosthesis.At a later date, the patient replaced the malleable device with a new ipp due to the patient's preference.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
• MDR Report Key: 19193695
• MDR Text Key: 341299228
• Report Number: MW5154348
• 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: Unknown
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention