MAUDE Adverse Event Report: COLOPLAST A/S COLOPLAST TITAN TOUCH 75 ML; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Model Number ER8075

Device Problems Inflation Problem (1310); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Deformity/ Disfigurement (2360); Dyspareunia (4505)

Event Date 10/25/2021

Event Type  malfunction  

Event Description

Middle aged patient with history of organic erectile disfunction, secondary to a traumatic brain injury, had a coloplast titan penile prosthesis placed in the last year.The device stopped working and caused a deformity of his penis which resulted in painful intercourse.The malfunction was described non-functioning with significant auto-inflation.Patient requested removal and replacement with another implant.

• Brand Name: COLOPLAST TITAN TOUCH 75 ML
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapollis MN 55411
• MDR Report Key: 12711013
• MDR Text Key: 278783749
• Report Number: 12711013
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ER8075
• Device Catalogue Number: ER8075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17520 DA
• Patient Weight: 83