MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29202400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 06/22/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the device was infected.The device was explanted and replaced with a genesis malleable.

Manufacturer Narrative

This follow-up was created to document the additional patient and event information.

Event Description

Additional information received stated infection and inflammatory reaction.Continued to have some scrotal drainage at follow-up appointment in (b)(6) 2019.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9512514
• MDR Text Key: 172602654
• Report Number: 2125050-2019-01144
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 6674064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 93