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

Catalog Number	ES8818
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Anxiety (2328); Distress (2329)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the patient stated that one of the cylinders is pushing against the tip of his penis [impending erosion].The patient's urologist advised that he has to keep his implant deflated or else it could push through the penis and cause an infection.The patient is going to be seeing a different urologist to have revision surgery.
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.Coloplast has not received information that the device has been explanted at this time.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
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 to be associated.Coloplast has not received information that the device has been explanted at this time.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 mw5170047: patient had a penile prosthesis implant in 2019.Last year patient was diagnosed with a faulty penile pump with pump erosion.There are two cylinders in the pump and one cylinder is pushing out against the patient's skin.The issue flares up once the pump is inflated.Patient states the prosthesis is a recalled device.Recall status was established (b)(6) 2021.Recall number is z04882021.Patient states the manufacturer failed their obligation to notify all patients.Patient perceives that the device could have been faulty from the start with an expiration/used by date of july 8, 2024.Since 2024, patient has been seen by doctor and patient is having a revision surgery where the implant is being replaced by a boston scientific prosthesis.Patient has hypertension, hypothyroidism, anxiety, and post-traumatic stress disorder.Patient also has prostate cancer in remission and had prostate removed in 2024.

• 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: 22004938
• Report Number: 2125050-2025-00813
• Device Sequence Number: 15216691
• Product Code: FHW
• UDI-Device Identifier: 05708932487221
• UDI-Public: 05708932487221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 07/08/2024
• Device Catalogue Number: ES8818
• Device Lot Number: 6949383_ES88182400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 05/12/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White