MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH NB SCROT ZERO 14CM; INFLATABLE PENILE PROSTHESIS

Model Number EN29141022

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 06/22/2017

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, malfunction, cylinder fracture.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and additional information, implant date.A titan touch pump and two cylinders were received for evaluation.A small aneurysm was noted in the bladder of cylinder 1 near the base.No visual or functional abnormalities were noted with the pump or cylinder 2.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.The information received indicated a cylinder fracture.Examination of the returned components revealed an aneurysm in cylinder 1 which was not a site of leakage.Based on examination of the returned product and the available information, quality concluded that the aneurysm may have occurred due to over-pressurization of the cylinder during the implant procedure and was the reason for return.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 NB SCROT ZERO 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7335002
• MDR Text Key: 102246099
• Report Number: 2125050-2018-00209
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EN29141022
• Device Catalogue Number: EN29141022
• Device Lot Number: 5493080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR