MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC TITAN OTR WITH 75ML C1 RESERVE; PENILE PROSTHESIS

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 08/27/2018

Event Type  Injury  

Event Description

Failure of penile prosthesis with likely leak, the device no longer inflated since (b)(6) 2018.Prosthesis placed (b)(6) 2013.

• Brand Name: TITAN OTR WITH 75ML C1 RESERVE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 7885245
• MDR Text Key: 120775563
• Report Number: MW5079860
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75