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

Catalog Number	ES2818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
Event or Problem Description
According to the available information, the device was explanted and replaced due to tubing exit breach [fracture].
Additional Manufacturer Narrative
The titan touch pump and cylinders were returned for analysis.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 the exhaust tubing of cylinder 1 and cylinder 2.A separation, surrounded by abrasion, was noted on the exhaust tubing of cylinder 1.This was a site of leakage.No functional abnormalities were noted with cylinder 2.Based on examination of the returned product, it was concluded that the abrasion marks noted on both exhaust tubes and inlet tube of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo enough to cause a separation.A separation of this type could then allow the loss of fluid, making the device inoperable.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, nonconformance's 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22737569
• Report Number: 2125050-2025-01266
• Device Sequence Number: 12544048
• Product Code: FHW
• UDI-Device Identifier: 05708932539128
• UDI-Public: 05708932539128
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/27/2025

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: ES2818
• Device Lot Number: 8459030_ES28182400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• 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: 08/07/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: 74 YR
• Patient Sex: Male