MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS

Model Number ES29222400

Device Problems Deflation Problem (1149); Inflation Problem (1310); Positioning Problem (3009)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Event Description

According to available information, this device required intervention due to difficult deflation.The pump seems to have scarred in too high and deep in the scrotum.Patient is having difficulty finding the deflate mechanism and deflating the device.Patient was educated on the device, showed samples and nurse practitioner helped him inflate and deflate the device.Patient may need a repositioning of the pump revision to make it more accessible, but he is unsure at this time.The device appears to be working properly.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16752997
• MDR Text Key: 313427177
• Report Number: 2125050-2023-00418
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539203
• UDI-Public: 05708932539203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 8659837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR