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

Catalog Number	ES8822
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
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 in veeva to be associated.
Event or Problem Description
According to the available information, the device was explanted and replaced due to a hole in the pump.
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 conforming reports that were confirmed in veeva to be associated.This lot number is associated to a capa that has been historically opened for the titan pump product line to investigate pump fractures.Information available at this time suggests the event falls within scope of titan recall z-0488-2021; it was determined that the most probable root cause was related to fatigue and tear resistance of the silicone elastomer used for the pump.
Additional Manufacturer Narrative
This report is to correct the coding for the h6.
Additional Manufacturer Narrative
Titan pump, cylinders 1 and 2, and reservoir were received for evaluation.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.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 conforming reports that were confirmed in veeva to be associated.This lot number is associated to capa 618925 that has been historically opened for the titan pump product line to investigate pump fractures.

• 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: 22776739
• Report Number: 2125050-2025-01280
• Device Sequence Number: 9449646
• Product Code: FHW
• UDI-Device Identifier: 05708932487269
• UDI-Public: 05708932487269
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 11/17/2025

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: 10/06/2024
• Device Catalogue Number: ES8822
• Device Lot Number: 7108124_ES88222400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/25/2025; 10/24/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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: 55 YR
• Patient Sex: Male