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 |