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

Catalog Number ES8922

Device Problem Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  Injury  

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.

Event Description

According to the available information the implant was explanted and replaced due to frozen pump.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Type of Device: 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: 18307189
• MDR Text Key: 330221531
• Report Number: 2125050-2023-01555
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487382
• UDI-Public: 05708932487382
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ES8922
• Device Lot Number: 6837845_ES89222400
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male