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

Catalog Number	EN2918
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
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, during implantation there was an aneurysm on both narrow cylinders on test inflation.It started after mild modeling.A new device was used to successfully complete the procedure.
Additional Manufacturer Narrative
Titan touch pump and cylinders 1 and 2 were received for evaluation.No functional abnormalities were noted with the pump.An aneurysm was noted on the bladder of cylinder 1.This was not a site of leakage.No functional abnormalities were noted with cylinder 2.Based on the procedures by which this device is tested prior to release, specific to revealing an aneurysm, it was concluded this most likely occurred subsequent to the opening of the device packaging.In addition this most likely occurred as the result of overinflation and/or excessive manipulation during the attempt to correct the observed penile curvature.This device is capable of generating pressure sufficient to aneuryze an unrestricted bladder.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information, during implantation there was an aneurysm on both narrow cylinders on test inflation.It started after mild modeling.A new device was used to successfully complete the procedure.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22485185
• Report Number: 2125050-2025-01132
• Device Sequence Number: 20999963
• Product Code: FHW
• UDI-Device Identifier: 05708932072564
• UDI-Public: 05708932072564
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: EN2918
• Device Lot Number: 10193604_EN29182400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• 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: 07/11/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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
• Patient Age: 64 YR
• Patient Sex: Male