MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL 20CM; INFLATABLE PENILE PROSTHESIS

Model Number QS89201400

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/20/2017

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 the available information, device tubing break.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan genesis pump, two cylinders, and a piece of detached connector tubing were received for evaluation.Examination and testing of the returned components revealed an aneurysm in the bladder of cylinder #1.Testing revealed this to be a site of leakage.No functional abnormalities are noted with the pump, cylinder #2, or the detached connector tubing.Quality concluded that while in-vivo enough pressure may have been exerted to result in an aneurysm on the bladder of cylinder 2.Quality further concluded that this pressure, in combination with device usage, could contribute to sufficient stress (s) to separate the bladder at this site.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 SCROTAL 20CM
• 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: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6941884
• MDR Text Key: 89223114
• Report Number: 2125050-2017-00503
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS89201400
• Device Catalogue Number: QS89201400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• 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: 75 YR