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

Catalog Number	E17924
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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 was not returned for evaluation.Without the benefit of analyzing the device, coloplast cannot comment on the condition of the device.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 device was explanted and replaced due to there being air in the device.
Additional Manufacturer Narrative
According to the available information this inflatable penile prosthesis was replaced due to air in the device.The pump, cylinders and reservoir were returned for testing.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation was noted on the pump bulb.This is a site of leakage.The surfaces appear to be non-striated, dull, and smooth, indicating that sufficient stress(s) was exerted.No functional abnormalities were noted with cylinder 1 or cylinder 2.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the non-striated, dull, and smooth surfaces associated with the separation indicate that sufficient stress was exerted on the pump bulb.A separation of this type could then allow the loss of fluid, making the device inoperable.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 that were confirmed in veeva to be associated.This lot number is associated with the titan recall z-0488-2021 which has been historically opened for the titan pump product line to investigate pump fractures.It was determined that the most probable root cause was related to fatigue and tear resistance of the silicone elastomer used for the pump.

• 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: 23058534
• Report Number: 2125050-2025-01470
• Device Sequence Number: 8581850
• Product Code: FHW
• UDI-Device Identifier: 05708932487429
• UDI-Public: 05708932487429
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: Lay User/Patient
• Device Expiration Date: 01/16/2025
• Device Catalogue Number: E17924
• Device Lot Number: 7263799_E179242400
• 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
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0488-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male