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

Model Number ES29182400

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 03/06/2018

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 or 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 break from cylinder to pump.

Manufacturer Narrative

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.

Event Description

According to the available information, tubing break from cylinder to pump.Additional information received indicated the ipp was originally placed in 2005.The malfunction was noted about 2016.The device was "working good" for about 10 years.The patient believes that his penile length is shorter post-ipp than before.In about 2016, the device stopped working, the patient would press the pump as usual, but the cylinders would not inflate.The doctor stated, upon pressing the pump, cylinders do not inflate, pump stays deflated (c/w leak).In the or, the proximal portion of the tubing on the patient's right cylinder appeared to be the source of leakage, with a partial break in the tubing.

• 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
• MDR Report Key: 7487736
• MDR Text Key: 107378785
• Report Number: 2125050-2018-00350
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539180
• UDI-Public: 05708932539180
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29182400
• Device Catalogue Number: ES29182400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR