MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

Catalog Number	ES8820
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Erosion (1750); Discomfort (2330)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
Event or Problem Description
According to the available information, the implant was removed and replaced with an ams device due to mechanical complication and displacement of penile implant.It was noted the patient began experiencing an aneurysmal defect in the more right proximal aspect of his penis causing discomfort and malfunction.This is the mechanical complication as well as the displacement of his implant.At this point, the surgeon and patient agreed that it would benefit the patient to remove and replace the implant.It was discussed placing his pump more posteriorly as the pump rubs against his clothes and gym wear and is very sensitive.During surgery it was noted there was a slight opening in the right corpora indicating the site of the aneurysm.This tissue was somewhat tinned out as well.This report captures the aneurysmal defect and mechanical complication.
Event or Problem Description
According to the available information, the implant was removed and replaced with an ams device due to mechanical complication and displacement of penile implant.It was noted the patient began experiencing an aneurysmal defect in the more right proximal aspect of his penis causing discomfort and malfunction.This is the mechanical complication as well as the displacement of his implant.At this point, the surgeon and patient agreed that it would benefit the patient to remove and replace the implant.It was discussed placing his pump more posteriorly as the pump rubs against his clothes and gym wear and is very sensitive.During surgery it was noted there was a slight opening in the right corpora indicating the site of the aneurysm.This tissue was somewhat tinned out as well.This report captures the aneurysmal defect and mechanical complication.
Additional Manufacturer Narrative
Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.Abrasion was noted on both cylinders near the strain relief.An aneurysm was noted on the bladder of cylinder 2.This was not a site of leakage.No functional abnormalities were noted with cylinder 1.No functional abnormalities were noted with the reservoir.Based on examination, it was concluded that while in-vivo enough pressure may have been exerted to result in an aneurysm on the bladder of cylinder 2.The device is capable of generating pressure sufficient to cause an aneurysm in an unrestricted bladder.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 25046604
• Report Number: 2125050-2026-00707
• Device Sequence Number: 9921324
• Product Code: FHW
• UDI-Device Identifier: 05708932487245
• UDI-Public: 5708932487245
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: ES8820
• Device Lot Number: 9534639_ES88202400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Unknown