MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS

Model Number ES29221022

Device Problem Inflation Problem (1310)

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

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.

Event Description

According to the available information, half a year after implant, the patient began to feel poor filling of the cylinders.After one year, the cylinders stopped filling at all.

Manufacturer Narrative

A titan touch pump was received for evaluation.No functional abnormalities were noted with the pump.The surfaces of the tubing detachment ends showed them to have uniform striations, indicating contact with sharp instrumentation.The inlet tubing and connector were detached to allow testing.No functional abnormalities were noted with the tubing or connector.The surfaces of the tubing detachment ends showed them to have uniform striations.Because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11201443
• MDR Text Key: 227766908
• Report Number: 2125050-2021-00071
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29221022
• Device Catalogue Number: ES2922
• Device Lot Number: 6565126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 04/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR