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

Catalog Number	517770 / 90-9000KC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
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.The device remains implanted.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 patient will be having a revision surgery due to leak.The revision surgery has not yet been completed.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance with procedures.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, nonconformances and capas revealed no trends for this lot.
Event or Problem Description
According to additional information received, the device was explanted and replaced on (b)(6) 2026 due to a break in the tubing.

• 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: 23743984
• Report Number: 2125050-2025-01894
• Device Sequence Number: 18679636
• Product Code: FHW
• UDI-Device Identifier: 05708932319621
• UDI-Public: 5708932319621
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 03/10/2026

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: 03/23/2026
• Device Catalogue Number: 517770 / 90-9000KC
• Device Lot Number: 7945534_5177701400
• Was Device Available for Evaluation?: No
• 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: 12/08/2025
• Supplement Report FDA Received Date: 02/13/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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: 54 YR
• Patient Sex: Unknown