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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, impotence, mechanical/hydraulic
Regulation Description Penile inflatable implant.
Definition PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product CodeFHW
Regulation Number 876.3350
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020
5 10 1 2 2 3 0

Device Problems
Insufficient Information 1576
Fluid Leak 979
Inflation Problem 899
Mechanical Problem 772
Material Puncture / Hole 358
Adverse Event Without Identified Device or Use Problem 332
Break 330
Defective Device 320
Migration 257
Leak / Splash 233
Inadequacy of Device Shape and/or Size 219
Deflation Problem 152
Failure to Cycle 122
Degraded 120
Collapse 111
Pumping Problem 97
Fracture 94
Malposition of device 74
Use of Device Problem 59
Material Deformation 54
Material Rupture 39
Device Inoperable 35
Positioning Problem 31
Material Protrusion / Extrusion 28
Material Split, Cut or Torn 27
Free or Unrestricted Flow 27
Migration or Expulsion of Device 27
Infusion or Flow Problem 24
Crack 17
Connection Problem 14
Device Appears to Trigger Rejection 12
Gas Leak 10
Mechanical Jam 10
Pump 10
Cylinder 8
Device Operates Differently Than Expected 7
Material Twisted / Bent 7
Hole In Material 6
Material Perforation 5
Extrusion 5
Noise, Audible 4
Device Markings / Labelling Problem 4
Loose or Intermittent Connection 4
Material Erosion 4
Deformation Due to Compressive Stress 3
Torn Material 3
Material Frayed 3
Difficult to Insert 2
Labelling, Instructions for Use or Training Problem 2
Material Discolored 2
Improper Flow or Infusion 2
Device Contaminated during manufacture or shipping 2
Tube 2
Material Too Rigid or Stiff 1
Cut In Material 1
Device Dislodged or Dislocated 1
Patient Device Interaction Problem 1
Reservoir 1
Device Contamination with Chemical or Other Material 1
Tear, Rip or Hole in Device Packaging 1
Material Separation 1
Excess Flow or Over-Infusion 1
Decrease in Pressure 1
Device Slipped 1
Contamination / decontamination Problem 1
Device Operational Issue 1
No Apparent Adverse Event 1
Incomplete or Inadequate Connection 1
Corroded 1
Entrapment of Device 1
Short Fill 1
Structural Problem 1
Difficult or Delayed Activation 1
Patient-Device Incompatibility 1
Detachment of Device or device Component 1
Naturally Worn 1
Contamination During Use 1
Material Fragmentation 1
Total Device Problems 7569


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