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

Catalog Number	ER8125
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Blister (4537)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the patient developed a blister on the abdomen outside the reservoir, which ended up becoming an infection.Patient had the device removed.Additionally, the patient mentioned the cylinder had moved down three inches.His urologist was on vacation and wanted him to wait and see if the infection would clear and prescribed antibiotics.He ended up contacting two other urologists.One told him to have the device removed while the other informed him to the er.The patient also reports that he has been in pain for the past five years.
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.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.

• 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 (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24654007
• Report Number: 2125050-2026-00417
• Device Sequence Number: 20253183
• Product Code: FHW
• UDI-Device Identifier: 05708932473927
• UDI-Public: 5708932473927
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 09/15/2026
• Device Catalogue Number: ER8125
• Device Lot Number: 8181692_ER81252400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• 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: 46 YR
• Patient Sex: Unknown