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

Model Number ES28222400

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, patient had titan touch implanted but complains that the device never works, c/o pain, and worsening leftward curvature.Device was explanted and replaced with an ams device.No other adverse patient effects were reported.

Manufacturer Narrative

Titan touch pump, and cylinders 1 and 2 were received for evaluation.Abrasion was noted on all tubes of the pump.No functional abnormalities were noted with the pump.Abrasion was noted on the exhaust tubes of both cylinders.No functional abnormalities were noted with either cylinder.The information received indicated the device did not work, pain and worsening leftward curvature, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.Because examination of the returned components may not conclusively confirm or disprove the report of pain, quality accepts the physician¿s observations of such as the reason for surgical intervention a review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

Event Description

According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2017 and revised on (b)(6) 2021 due to the patient stating the device never works, c/o pain, and worsening leftward curvature.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12706390
• MDR Text Key: 278634878
• Report Number: 2125050-2021-01550
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539142
• UDI-Public: 05708932539142
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2022
• Device Model Number: ES28222400
• Device Catalogue Number: ES2822
• Device Lot Number: 5537093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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: 54 YR
• Patient Sex: Male