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

Catalog Number	ES8822
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, during a virgin implant surgery, there was a leak identified in the cylinder at the conclusion of the case.The device was removed and replaced with a new device.
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.
Event or Problem Description
According to the available information, during a virgin implant surgery, there was a leak identified in the cylinder at the conclusion of the case.The device was removed and replaced with a new device.
Additional Manufacturer Narrative
Titan pump and cylinders 1 and 2 were received for evaluation.No functional abnormalities were noted with the pump.A separation was noted on the bladder of cylinder 1.This is a site of leakage.The separation has a central groove, indicating contact with sharp instrumentation such as a needle.No functional abnormalities were noted with cylinder 2.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the bladder of cylinder 1 occurred subsequent to the device packaging being opened.The information received indicated leak was identified in the cylinder at the conclusion of the case.Based on the evaluation and information received, the separation most likely occurred inadvertently during the implant procedure.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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21993857
• Report Number: 2125050-2025-00797
• Device Sequence Number: 4478217
• Product Code: FHW
• UDI-Device Identifier: 05708932487269
• UDI-Public: 05708932487269
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/03/2025

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: Health Professional
• Device Catalogue Number: ES8822
• Device Lot Number: 9911391_ES88222400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• 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: 05/09/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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: 66 YR
• Patient Sex: Male