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

Catalog Number	ES8924
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
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 to be associated.The device remains implanted at this time.Without the benefit of analyzing the device, quality 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.
Event or Problem Description
According to the available information three weeks after receiving the implant, the patient went to see the implanting doctor to learn how to start inflating his implant.The implant worked fine and four days later, the patient tried to inflate the implant and the bulb went flat.The implant doctor ordered an mri and the results showed the fluid had leaked.Patient will be undergoing a revision surgery, but no date has been scheduled yet.
Additional Manufacturer Narrative
Correction: b1: added adverse event.E: added e1.Initial reporter & e1.Reporter's contact information.Additional info includes explant, explant date.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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 the available information three weeks after receiving the implant, the patient went to see the implanting doctor to learn how to start inflating his implant.The implant worked fine and four days later, the patient tried to inflate the implant and the bulb went flat.The implant doctor ordered an mri and the results showed the fluid had leaked.Patient underwent revision surgery.
Additional Manufacturer Narrative
Additional info includes explant, explant date.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance with procedures.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, nonconformance's and capas revealed no trends for this lot.
Event or Problem Description
According to the available information three weeks after receiving the implant, the patient went to see the implanting doctor to learn how to start inflating his implant.The implant worked fine and four days later, the patient tried to inflate the implant and the bulb went flat.The implant doctor ordered an mri and the results showed the fluid had leaked.Patient underwent revision surgery.
Additional Manufacturer Narrative
Titan pump, cylinders 1 and 2, reservoir, detached connector /exhaust tubing, and detached connector /inlet tubing were received for evaluation.No functional abnormalities were noted with the pump.No functional abnormalities were noted with either cylinder 1 or cylinder 2.A group of striations, indicating contact with unshod instrumentation, was noted on the inlet tube of the reservoir.This is a site of leakage.No functional abnormalities were noted the detached connector /exhaust tubing.No functional abnormalities were noted the detached connector /inlet tubing.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the inlet tube of the reservoir occurred after the device packaging was opened.The information received indicated that there was leakage noted on the device.Based on the evaluation, information received, and brief period in-vivo, the separation most likely occurred inadvertently during the implant procedure.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.
Event or Problem Description
According to the available information three weeks after receiving the implant, the patient went to see the implanting doctor to learn how to start inflating his implant.The implant worked fine and four days later, the patient tried to inflate the implant and the bulb went flat.The implant doctor ordered an mri and the results showed the fluid had leaked.Patient underwent revision surgery.

• 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: 23088995
• Report Number: 2125050-2025-01485
• Device Sequence Number: 21453838
• Product Code: FHW
• UDI-Device Identifier: 05708932768139
• UDI-Public: 05708932768139
• 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: 2025
• 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,Followup,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: ES8924
• Device Lot Number: 10193583_ES89242400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/13/2025; 11/13/2025; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: 62 YR
• Patient Sex: Unknown