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

Model Number ES29202400

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.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, cracked black tubing leading from the pump to the reservoir.The cylinder and pump were removed and another complete device was implanted.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device and corrected implant date.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.A titan touch pump and two cylinders were received for evaluation.The inlet tube with connector was detached for testing.Examination and testing of the returned components revealed a separation within abrasion on the inlet tube of the pump.Testing revealed this to be a site of leakage.Partial separations within abrasion were noted on both exhaust tubes of the pump.Testing revealed these to not be sites of leakage.Abrasion was also noted on the exhaust tube of cylinder 1.No functional abnormalities were noted with either cylinders or detached inlet tube with connector.Based on examination of the returned product, it was concluded that while in-vivo all pump tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the inlet tubing of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9319526
• MDR Text Key: 166305495
• Report Number: 2125050-2019-01015
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 4029485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR