TITAN TOUCH

INFLATABLE PENILE PROSTHESIS

This device is manufactured by COLOPLAST A/S.

The following problems were reported about this device:

Year Description Events/year Type
2023 Unspecified Infection 9 Patient
2023 Hematoma 1 Patient
2023 Erosion 6 Patient
2023 Discomfort 2 Patient
2023 Unintended Deflation 1 Device
2023 Pumping Problem 9 Device
2023 Positioning Problem 2 Device
2023 Physical Resistance/Sticking 3 Device
2023 Migration 4 Device
2023 Material Twisted/Bent 2 Device
2023 Material Too Rigid or Stiff 1 Device
2023 Material Split, Cut or Torn 1 Device
2023 Material Puncture/Hole 3 Device
2023 Material Protrusion/Extrusion 1 Device
2023 Material Frayed 2 Device
2023 Material Deformation 1 Device
2023 Insufficient Information 4 Device
2023 Inflation Problem 7 Device
2023 Inadequacy of Device Shape and/or Size 5 Device
2023 Improper or Incorrect Procedure or Method 1 Device
2023 Fracture 25 Device
2023 Fluid/Blood Leak 23 Device
2023 Failure to Pump 3 Device
2023 Device Dislodged or Dislocated 2 Device
2023 Crack 2 Device
2023 Break 2 Device
2023 Adverse Event Without Identified Device or Use Problem 12 Device
2022 Unspecified Infection 1 Patient
2022 Pumping Problem 10 Device
2022 Positioning Problem 3 Device
2022 Physical Resistance/Sticking 1 Device
2022 Migration or Expulsion of Device 2 Device
2022 Migration 7 Device
2022 Material Twisted/Bent 3 Device
2022 Material Split, Cut or Torn 1 Device
2022 Material Puncture/Hole 4 Device
2022 Material Perforation 1 Device
2022 Material Erosion 1 Device
2022 Malposition of Device 1 Device
2022 Insufficient Information 5 Device
2022 Inflation Problem 14 Device
2022 Inadequacy of Device Shape and/or Size 5 Device
2022 Fracture 23 Device
2022 Fluid/Blood Leak 25 Device
2022 Filling Problem 1 Device
2022 Failure to Cycle 1 Device
2022 Deflation Problem 1 Device
2022 Break 1 Device
2022 Appropriate Term/Code Not Available 7 Device
2022 Adverse Event Without Identified Device or Use Problem 19 Device
2021 Pumping Problem 1 Device
2021 Mechanical Problem 1 Device
2021 Inflation Problem 2 Device
2019 Structural Problem 1 Device
2019 Pumping Problem 32 Device
2019 Positioning Problem 4 Device
2019 Patient-Device Incompatibility 1 Device
2019 Migration or Expulsion of Device 3 Device
2019 Migration 8 Device
2019 Mechanical Problem 30 Device
2019 Mechanical Jam 7 Device
2019 Material Twisted/Bent 2 Device
2019 Material Rupture 1 Device
2019 Material Puncture/Hole 8 Device
2019 Material Protrusion/Extrusion 6 Device
2019 Material Perforation 2 Device
2019 Material Erosion 1 Device
2019 Material Deformation 1 Device
2019 Leak/Splash 39 Device
2019 Insufficient Information 45 Device
2019 Inflation Problem 14 Device
2019 Inadequacy of Device Shape and/or Size 13 Device
2019 Free or Unrestricted Flow 2 Device
2019 Fracture 14 Device
2019 Fluid/Blood Leak 2 Device
2019 Device Appears to Trigger Rejection 2 Device
2019 Deflation Problem 2 Device
2019 Crack 2 Device
2019 Connection Problem 1 Device
2019 Break 35 Device
2019 Adverse Event Without Identified Device or Use Problem 22 Device
2018 Torn Material 1 Device
2018 Sticking 3 Device
2018 Short Fill 1 Device
2018 Pumping Problem 25 Device
2018 Positioning Problem 8 Device
2018 Migration or Expulsion of Device 5 Device
2018 Mechanical Problem 13 Device
2018 Mechanical Jam 2 Device
2018 Material Twisted/Bent 1 Device
2018 Material Separation 1 Device
2018 Material Rupture 7 Device
2018 Material Puncture/Hole 4 Device
2018 Material Protrusion/Extrusion 5 Device
2018 Material Perforation 2 Device
2018 Material Erosion 3 Device
2018 Material Deformation 3 Device
2018 Malposition of Device 2 Device
2018 Leak/Splash 21 Device
2018 Insufficient Information 58 Device
2018 Infusion or Flow Problem 2 Device
2018 Inflation Problem 17 Device
2018 Inadequacy of Device Shape and/or Size 21 Device
2018 Hole In Material 5 Device
2018 Free or Unrestricted Flow 3 Device
2018 Fracture 10 Device
2018 Fluid/Blood Leak 6 Device
2018 Failure to Pump 2 Device
2018 Extrusion 5 Device
2018 Device Slipped 1 Device
2018 Device Operates Differently Than Expected 12 Device
2018 Device Inoperable 17 Device
2018 Device Appears to Trigger Rejection 1 Device
2018 Detachment of Device or Device Component 1 Device
2018 Deformation Due to Compressive Stress 2 Device
2018 Deflation Problem 7 Device
2018 Cut In Material 1 Device
2018 Crack 5 Device
2018 Collapse 1 Device
2018 Break 21 Device
2018 Appropriate Term/Code Not Available 3 Device
2018 Adverse Event Without Identified Device or Use Problem 4 Device
2017 Use of Device Problem 2 Device
2017 Sticking 4 Device
2017 Split 1 Device
2017 Self-Activation or Keying 2 Device
2017 Pumping Problem 2 Device
2017 Positioning Problem 8 Device
2017 Physical Property Issue 1 Device
2017 Patient-Device Incompatibility 3 Device
2017 Migration or Expulsion of Device 3 Device
2017 Mechanics Altered 1 Device
2017 Material Too Rigid or Stiff 1 Device
2017 Material Split, Cut or Torn 1 Device
2017 Material Puncture/Hole 1 Device
2017 Material Protrusion/Extrusion 1 Device
2017 Material Perforation 1 Device
2017 Material Integrity Problem 1 Device
2017 Material Erosion 5 Device
2017 Material Deformation 1 Device
2017 Malposition of Device 3 Device
2017 Leak/Splash 13 Device
2017 Kinked 3 Device
2017 Insufficient Information 27 Device
2017 Infusion or Flow Problem 1 Device
2017 Inflation Problem 6 Device
2017 Inadequacy of Device Shape and/or Size 12 Device
2017 Hole In Material 7 Device
2017 Fracture 6 Device
2017 Fluid/Blood Leak 10 Device
2017 Filling Problem 1 Device
2017 Failure to Pump 3 Device
2017 Extrusion 6 Device
2017 Difficult to Remove 1 Device
2017 Device Slipped 2 Device
2017 Device Operates Differently Than Expected 32 Device
2017 Device Inoperable 7 Device
2017 Detachment of Device or Device Component 1 Device
2017 Detachment Of Device Component 1 Device
2017 Deflation Problem 4 Device
2017 Crack 6 Device
2017 Contamination 1 Device
2017 Computer Operating System Problem 1 Device
2017 Component Missing 1 Device
2017 Collapse 1 Device
2017 Break 16 Device
2017 Bent 1 Device
2017 Appropriate Term/Code Not Available 4 Device
2017 Adverse Event Without Identified Device or Use Problem 23 Device
2016 Material Erosion 1 Device
2016 Leak/Splash 1 Device
2016 Insufficient Information 9 Device
2016 Fluid/Blood Leak 1 Device
2016 Disconnection 1 Device
2016 Device Operates Differently Than Expected 2 Device
2016 Deflation Problem 1 Device
2016 Adverse Event Without Identified Device or Use Problem 4 Device
2015 Insufficient Information 1 Device
2015 Fracture 1 Device
2015 Difficult to Remove 1 Device
2015 Device Inoperable 1 Device
2015 Contamination 1 Device
2015 Appropriate Term/Code Not Available 1 Device
2015 Adverse Event Without Identified Device or Use Problem 1 Device
2014 Hole In Material 1 Device
2014 Connection Problem 1 Device
2014 Collapse 1 Device