MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29161022

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, tubing leakage.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device, and the additional lot number and patient information received.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation at the strain relief/exhaust tube junction of cylinder #1.Testing revealed this to be a site of leakage.The separation appears to be within an area of confined abrasion.A partial separation within abrasion is noted at the exhaust tube/strain relief junction of cylinder #2.Testing revealed this not to be a site of leakage.Surface abrasion is noted on all tubes and all strain relief of the pump.No functional abnormalities are noted with cylinder #2 or the pump.Based on quality's examination, quality concluded that while in-vivo both the exhaust tubes and inlet tube overlapped and abraded against one another.This most likely caused the exhaust tube of cylinder #1 to be kinked onto itself, abrading enough to cause a separation in the tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 16CM
• 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 ; 6123024983
• MDR Report Key: 7270091
• MDR Text Key: 100054903
• Report Number: 2125050-2018-00159
• 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,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29161022
• Device Catalogue Number: ES29161022
• Device Lot Number: 4455031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR