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

Model Number ES29202400

Device Problems Crack (1135); Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Split, Cut or Torn (4008)

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

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, this device was explanted and replaced due to an unspecified mechanical malfunction.No other adverse patient effects were reported.

Event Description

Additional information received further reported a crack/tear in the left "lhs" tubing.There was no fluid in the system.

Manufacturer Narrative

A titan touch pump and cylinders 1 and 2 were received for evaluation.A separation was noted within abrasion on the longer exhaust tube of the pump.This is a site of leakage.Partial separations within abrasion were noted on the shorter exhaust tube of the pump.These were not sites of leakage.Abrasion was also noted on the inlet tube of the pump.No functional abnormalities were noted with either cylinder.Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to cause a separation through the longer exhaust tubing of the pump at this site.A separation of this type may then allow the loss of fluid, making the device inoperable.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
• MDR Report Key: 12014381
• MDR Text Key: 256706745
• Report Number: 2125050-2021-00760
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2019
• Device Model Number: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 4084939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 09/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention