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

Model Number 5191702400

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem No Information (3190)

Event Date 05/14/2019

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 the available information, the inflatable device was removed and replaced.

Manufacturer Narrative

This follow-up mdr is created to document the additional device and event information, and the conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Event Description

Additional information indicated the revision took place because the patient had a hard time working the one touch device.The physician was able to operate the device, but thought the patient would have an easier time with the titan genesis pump.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8764927
• MDR Text Key: 150160454
• Report Number: 2125050-2019-00556
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932519847
• UDI-Public: 05708932519847
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5191702400
• Device Catalogue Number: 519170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR