MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL BIOFLEX CYLINDER SET WITH PUMP; PENILE IMPLANT

Catalog Number 90-9918SNC

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 09/27/2017

Event Type  Injury  

Event Description

Patient with a history of erectile dysfunction and peyronie's disease, underwent penile implant on (b)(6) 2017.At some point, we became aware that the implant is not functioning and the patient is scheduled for a procedure to replace the implant on (b)(6) 2017.

• Brand Name: TITAN SCROTAL BIOFLEX CYLINDER SET WITH PUMP
• Type of Device: PENILE IMPLANT
• Manufacturer (Section D): COLOPLAST A/S; humlebaek 3050 ; DA 3050
• MDR Report Key: 7147712
• MDR Text Key: 95952372
• Report Number: MW5074251
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2017

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: No Information
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: 90-9918SNC
• Device Lot Number: 4487785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2017
• 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: 55 YR