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

Model Number ES29202400

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Because the available information did not indicate what factors may have contributed to the reported "malfunction", and because no functional abnormalities were noted, the cause of this reported event could not be determined.

Event Description

Follow up to mfr report # 2125050-2019-01060."according to the available information, a malfunction was reported.The inflatable penile prosthesis was explanted and a malleable device was implanted as a replacement.".

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12196717
• MDR Text Key: 262502976
• Report Number: 2125050-2021-00934
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 6928104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2019
• 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: 72 YR