MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC. PROSTHESIS, PENILE

Patient Problem Insufficient Information (4580)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent a surgical procedure to explant this unknown.Penile prosthesis for unspecified reasons.All components of the existing device were explanted and replaced with a new spectra penile prosthesis.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROSTHESIS, PENILE
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC.
• MDR Report Key: 19193845
• MDR Text Key: 341316435
• Report Number: MW5154354
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1