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

Catalog Number	ES8822
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the valve of the implant has "busted" [fractured], and fluid is reportedly everywhere in the patient's body.The patient feels a lot of pain and can hardly bend over.The patient went to their surgeon, but he refused the patient care.The patient has been to the emergency room, but they didn't do much since they don't have much information on the implants.The patient has seen a urologist that has advised the patient to have the implant replaced.
Additional Manufacturer Narrative
The lot number was found to be associated with the titan recall z-0488-2021, and the information available at this time suggests the event falls within scope.It was determined that the most probable root cause was related to fatigue and tear resistance of the silicone elastomer used for the pump.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 conforming reports that were confirmed in veeva to be associated.This lot number is associated to a capa that has been historically opened for the titan pump product line to investigate pump fractures.The device remains implanted.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.B3: date is unknown.

• 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: 21960000
• Report Number: 2125050-2025-00751
• Device Sequence Number: 21131667
• Product Code: FHW
• UDI-Device Identifier: 05708932487269
• UDI-Public: 05708932487269
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/10/2024
• Device Catalogue Number: ES8822
• Device Lot Number: 6828422_ES88222400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0488-2021
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Unknown