MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC TITAN TOUCH; INFLATABLE PENILE PROTHESIS

Model Number ES29182400

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, a patient is having issues deflating his implant.According to the physician the pump is positioned high in the scrotum and difficult to access.Additional info.Per tm on 12/28: " i have not received any update.No revision surgery is scheduled.".

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11175693
• MDR Text Key: 227036109
• Report Number: 2125050-2021-00068
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539180
• UDI-Public: 05708932539180
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 01/15/2021

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
• Device Operator: Health Professional
• Device Model Number: ES29182400
• Device Catalogue Number: ES2918
• Device Lot Number: 7525947
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1