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

Catalog Number	ER8125
Medical Device Problem Codes	Off-Label Use (1494); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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.
Event or Problem Description
According to the available information, the reservoir was removed and replaced for an unknown reason.
Additional Manufacturer Narrative
According to the available information the titan touch was implanted on (b)(6) 2024 and revised on (b)(6) 2024 due a potentially chronically infected reservoir and reservoir migration into the abdomen.The operative report noted the migration of the submuscular reservoir into the abdomen is rare, but not impossible and could have come from primary migration of the device through a thinned peritoneum or could have been exacerbated by the patient's need to wear heavy belt in the exact location of the reservoir position.Additionally, based on this patient history, it was noted this patient is transgender (gender affirmation case).The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of infection or reservoir migration, quality accepts the physician¿s observations of such as the reason for surgical intervention.The review of the device lot history record indicates this lot was processed through the validated sterilization cycle.Therefore, it was concluded the infection originated from source(s) other than the device.This case is considered off label use as the titan is indicated for male patients with erectile dysfunction.Therefore, this may have contributed to the reported adverse events.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
Event or Problem Description
According to additional information from an operative report that was received on 22-jan-2025, the patient developed appendicitis.During appendectomy, it became clear that he had intra-abdominal location of the reservoir [migration].The revision that occurred was to remove the potentially chronically infected reservoir and place a new reservoir in the left submuscular space.

• 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: 20568986
• Report Number: 2125050-2024-01764
• Device Sequence Number: 7827814
• Product Code: FHW
• UDI-Device Identifier: 05708932539111
• UDI-Public: 05708932539111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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 Catalogue Number: ER8125
• Device Lot Number: 9709712_ER81252400
• 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: 10/30/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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: 42 YR
• Patient Sex: Male