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

Catalog Number	EN2811
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the ipp wasn¿t working due to the pump being blocked.There was liquid loss from the tubing.The device was substituted with genesis.
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 nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information, the ipp wasn¿t working due to the pump being blocked.There was liquid loss from the tubing.The device was substituted with genesis.
Additional Manufacturer Narrative
Titan touch pump, cylinders 1 and 2, reservoir, and detached connector / inlet tubing were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.No functional abnormalities were noted with cylinder 1 or cylinder 2.No functional abnormalities were noted with the reservoir.A group of striations, indicating contact with unshod instrumentation, was noted on the detached inlet tube.This is a site of leakage.The device components were received detached.Examination of the surfaces of the tube detachment ends revealed markings indicating contact with sharp instrumentation across the entire cross-sectional surface.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed damage occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed damage would have resulted in an earlier detected fluid loss, it was concluded that the damage most likely occurred during or after explant.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: 18228775
• Report Number: 2125050-2023-01486
• Device Sequence Number: 12107539
• Product Code: FHW
• UDI-Device Identifier: 05708932539067
• UDI-Public: 05708932539067
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/26/2019
• Device Catalogue Number: EN2811
• Device Lot Number: 4191565_EN28111022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2014
• 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 Sex: Male