MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES28222400

Device Problem Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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, the clear tubing was frayed.The device was explanted and replaced.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump, two cylinders and reservoir were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion on the longer exhaust tube of the pump and inlet tube of the reservoir.Testing revealed these to be sites of leakage.Partial separations within abrasion were noted on the longer exhaust tube of the pump and inlet tube of the reservoir.Abrasion was also noted on all pump tubes, both cylinder exhaust tubes and reservoir inlet tube.No functional abnormalities were noted with the either cylinder.Based on examination of the returned product, it was concluded that while in-vivo the tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could most likely contribute to sufficient stress(s) to separate the longer exhaust tube of the pump and inlet tube of the reservoir.Separations of these types would then allow the loss of fluid, making the device inoperable.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.

• Brand Name: TITAN TOUCH INFR ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9563325
• MDR Text Key: 174101357
• Report Number: 2125050-2020-00018
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539142
• UDI-Public: 05708932539142
• 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
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28222400
• Device Catalogue Number: ES2822
• Device Lot Number: 3951087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR