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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the doctor implanted 16cm narrow cylinders with 2cm rear tip extenders in a patient that had peyronie's disease with a curvature of 45 degrees.Manual modeling was performed for 90 seconds.Doctor noticed a bubble herniation (aneurysm) on the cylinder formed on the proximal end near the clear tip.The cylinder was removed and replaced with 18cm narrow cylinders.Manual modeling was performed again and after 90 seconds, doctor noticed a similar bubble herniation (aneurysm) on the 18cm narrow cylinders at the proximal end near the clear tip.The cylinder was removed and replaced with 18cm standard cylinders.These were successfully implanted.Manual molding was attempted with no success.The doctor proceeded to perform a plication procedure.The case was completed following plication procedure with no further problems.This report captures the 18cm narrow cylinders.
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 capas that were confirmed to be associated.A non-conforming report [nc] was identified as associated with this lot number; however, the failure being reported in the complaint (aneurysm failure mode) is not related to the issue identified in the nc.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.The additional device with reported issue referenced in b5 is captured under a separate medwatch report.
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 2.This was not a site of leakage.No functional abnormalities were noted with cylinder 1.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.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 capas that were confirmed in veeva to be associated.An nc was identified as associated with this lot number; however, the failure being reported in the complaint is not related to the issue identified in the nc.
Event or Problem Description
According to the available information the doctor implanted 16cm narrow cylinders with 2cm rear tip extenders in a patient that had peyronie's disease with a curvature of 45 degrees.Manual modeling was performed for 90 seconds.Doctor noticed a bubble herniation (aneurysm) on the cylinder formed on the proximal end near the clear tip.The cylinder was removed and replaced with 18cm narrow cylinders.Manual modeling was performed again and after 90 seconds, doctor noticed a similar bubble herniation (aneurysm) on the 18cm narrow cylinders at the proximal end near the clear tip.The cylinder was removed and replaced with 18cm standard cylinders.These were successfully implanted.Manual molding was attempted with no success.The doctor proceeded to perform a plication procedure.The case was completed following plication procedure with no further problems.This report captures the 18cm narrow cylinders.

• 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: 23905871
• Report Number: 2125050-2025-01981
• Device Sequence Number: 10090145
• Product Code: FHW
• UDI-Device Identifier: 05708932072564
• UDI-Public: 5708932072564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/20/2026

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: Health Professional
• Device Catalogue Number: EN2918
• Device Lot Number: 10487463_EN29182400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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 Sex: Unknown