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

Catalog Number	ES2822
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the device was explanted and replaced due to a failure.It was reported the surgeon could not determine reason for failure.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report [nc] 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.An nc was identified as associated with this lot number.As part of the nc, any nonconforming product should have been sorted out.As no specific failure was reported we are unable to verify if the alleged issue relates to the identified nc.If the product is returned, evaluation regarding relationship between nc and confirmed failure will be made.
Event or Problem Description
According to the available information it was additionally reported that loss of fluid in the system was noticed after the device was explanted.According to the available information the device was explanted and replaced due to a failure.It was reported the surgeon could not determine reason for failure.
Event or Problem Description
According to the available information it was additionally reported that loss of fluid in the system was noticed after the device was explanted.According to the available information the device was explanted and replaced due to a failure.It was reported the surgeon could not determine reason for failure.
Additional Manufacturer Narrative
Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.No functional abnormalities were noted with the pump.A separation was noted on the exhaust tubing of cylinder 1.This is a site of leakage.The separation has a smooth, straight edge, indicating contact with sharp instrumentation.No functional abnormalities were noted with cylinder 2.No functional abnormalities were noted with the reservoir.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the exhaust tube of cylinder 1 occurred after the device packaging was opened.The information received indicated that there was a device failure.Based on the evaluation, information received, and brief period in-vivo, the separation most likely occurred inadvertently during the implant procedure.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.(b)(4) was identified as associated with this lot number.Based on the testing and examination of the returned product, the failure in the complaint is not related to the issue identified in the nc.

• 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: 22902904
• Report Number: 2125050-2025-01358
• Device Sequence Number: 8931845
• Product Code: FHW
• UDI-Device Identifier: 05708932539142
• UDI-Public: 05708932539142
• 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,Followup
• Report Date (Section B): 01/20/2026

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: ES2822
• Device Lot Number: 9915746_ES28222400
• 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; Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/06/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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: 72 YR
• Patient Sex: Unknown