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

Catalog Number	ES8918
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, during closure, the cylinder was punctured.The implant leaked over time.The device was explanted and replaced.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report [nc], and capa.No ncs nor capas were identified in veeva.There were several complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.The device was not returned for evaluation.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Additional Manufacturer Narrative
Correction to annex c and d coding.
Additional Manufacturer Narrative
Titan 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 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.No functional abnormalities were noted with the reservoir.Based on examination, it was concluded that the observed separation in the cylinder bladder would have allowed the reported ¿puncture¿ however, because the limited information provided does not indicate any factors that may have contributed to the reported event, and due to the brief period in-vivo, the sequence of events leading to the observed separation cannot be determined.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: 21910422
• Report Number: 2125050-2025-00699
• Device Sequence Number: 12943839
• Product Code: FHW
• UDI-Device Identifier: 05708932487344
• UDI-Public: 05708932487344
• 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: 2024
• 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): 08/21/2025

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: ES8918
• Device Lot Number: 9337619_ES89182400
• 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: 04/25/2025
• Supplement Report FDA Received Date: 05/23/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Unknown