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

Catalog Number	517750
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the device was explanted and replaced due to lack of fluid in system.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no non-conforming reports or capas that were confirmed to be associated.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.
Event or Problem Description
According to the available information the device was explanted and replaced due to lack of fluid in system.
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.A separation was noted on the longer exhaust tubing of the pump.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.A failure of the back pressure and inlet valve tests were noted with the pump as the balls in the pump failed to seat properly.It was determined that foreign material was noted in the spring/ball and seat component of the pump.Abrasion was noted on the exhaust tubing of cylinder 1.No functional abnormalities were noted with cylinder 1 or cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation indicate that sufficient stress was exerted on the longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.Review of the returned pump was conducted.During this review, it was concluded that the foreign material noted in the spring/ball and seat component of the pump resulted in the failure of the back pressure and inlet valve testing.Because these components were released according to manufacturing and quality control procedures, it was concluded that the foreign material observed most likely entered the system after the device packaging was opened.Failure of this test was not associated with the cause of the reported device malfunction.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.

• 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: 23828141
• Report Number: 2125050-2025-01936
• Device Sequence Number: 5068148
• Product Code: FHW
• UDI-Device Identifier: 05708932533966
• UDI-Public: 5708932533966
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Expiration Date: 05/03/2024
• Device Catalogue Number: 517750
• Device Lot Number: 6837855_5177502400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/17/2025
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• 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: 65 YR
• Patient Sex: Unknown