MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC TITAN OTR; PENILE PROSTHESIS

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2014

Event Type  malfunction  

Event Description

Malfunctioning penile prosthesis removed.
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manufacturer response for penile prosthesis, ipp (per site reporter).
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device has been returned to the manufacturer on 12/9.The device was not implanted at (b)(6).With the help of the manufacturer the serial and lot numbers were identified.

• Brand Name: TITAN OTR
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 w. river rd n; minneapolis MN 55411
• MDR Report Key: 4355859
• MDR Text Key: 5179189
• Report Number: 4355859
• Device Sequence Number: 1
• Product Code: FAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2014

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: Invalid Data
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2014
• Patient Sequence Number: 1
• Patient Age: 57 YR