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

Model Number ES28162400

Device Problem Material Erosion (1214)

Patient Problem Unspecified Infection (1930)

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, this device required replacement due to worn tubing.There was worn tubing at the exit site.An infection was also noted.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.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

Manufacturer Narrative

Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.Abrasion was noted on the exhaust tubes of cylinder 1 and cylinder 2.A separation was noted on the bladder of cylinder 1.This is a site of leakage.The separation has a central groove, indicating contact with sharp instrumentation such as a needle.No functional abnormalities were noted with cylinder 2.Abrasion was noted on the inlet tube of the reservoir.A group of striations, indicating contact with unshod instrumentation, was noted on the lockout reservoir valve.This is a site of leakage.The information received indicated the device had worn down tubing at the exit site, but because no functional abnormalities were noted with the returned components beside instrument damage, the complaint could not be confirmed as reported.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separations on the bladder of cylinder 1 and on the reservoir lockout valve occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separations most likely occurred during or after explant.These separations are not associated with the cause for failure.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.

• 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: 16877247
• MDR Text Key: 314649991
• Report Number: 2125050-2023-00517
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539111
• UDI-Public: 05708932539111
• 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,Followup,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2024
• Device Model Number: ES28162400
• Device Catalogue Number: ES2816
• Device Lot Number: 6663013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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: 56 YR
• Patient Sex: Male