MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29181022

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/21/2019

Event Type  Injury  

Manufacturer Narrative

A titan touch pump, two cylinders and a reservoir were returned for evaluation.Microscopic examination and testing of the returned components revealed surface abrasion on all pump tubing indicating that surfaces had come into repetitive contact.Microscopic examination of the bladder of cylinder 1 revealed a melted appearance that can result when a component comes into contact with a cauterizing tool.Testing revealed this to not be a site of leakage.No functional anomalies were noted with the pump, cylinders, or reservoir.The information received indicated there was leakage and fluid loss with the device, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.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, non-conformances and capas revealed no trends for this lot.

Event Description

According to the available information, the device was explanted and replaced due to fluid loss.Additional information received indicated that leakage site could not be found, but the system was empty.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 9512503
• MDR Text Key: 183710403
• Report Number: 2125050-2019-01169
• 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: distributor,foreign
• Type of Report: Initial
• Report Date: 12/22/2019

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: ES29181022
• Device Catalogue Number: ES2918
• Device Lot Number: 6401866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other