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

Model Number ES29202400

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The lot # 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.

Event Description

Arrording to available, thisdevice was explanted due to an errosion and was replaced it with a malliable device.

Manufacturer Narrative

Section d and h4 corrected from genesis to titan touch.

Manufacturer Narrative

According to the available information the inflatable device was implanted on 9/29/2016 and removed/replaced with a malleable device on 04/14/2021 due to erosion/extrusion on the right side.Examination of the returned components revealed no abnormalities that would have contributed to the report of erosion or extrusion.However, because examination of the returned components may not conclusively confirm or disprove the report of erosion or extrusion, quality accepts the physician¿s observations of such as the reason for surgical intervention.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11794199
• MDR Text Key: 250209499
• Report Number: 2125050-2021-00481
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• Combination Product (y/n): N
• PMA/PMN Number: K050248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2020
• Device Model Number: ES29202400
• Device Catalogue Number: 519260
• Device Lot Number: 4904039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 09/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR