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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)
2020 2021 2022 2023 2024 2025
4 2 3 3 3 0

MDR Year MDR Reports MDR Events
2020 3562 3562
2021 3719 3719
2022 3203 3203
2023 3675 3675
2024 4099 4099
2025 198 198

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4247 4247
Fluid/Blood Leak 3959 3959
Adverse Event Without Identified Device or Use Problem 3680 3680
Inflation Problem 3463 3463
Material Puncture/Hole 2687 2687
Fracture 1253 1253
Insufficient Information 1190 1190
Migration 1150 1150
Inadequacy of Device Shape and/or Size 820 820
Collapse 673 673
Deflation Problem 638 638
Malposition of Device 544 544
Defective Device 527 527
Break 424 424
Pumping Problem 399 399
Degraded 345 345
Appropriate Term/Code Not Available 212 212
Material Deformation 197 197
Leak/Splash 190 190
Air/Gas in Device 112 112
Failure to Cycle 95 95
Physical Resistance/Sticking 92 92
Material Split, Cut or Torn 83 83
Failure to Pump 81 81
Positioning Problem 79 79
Device Appears to Trigger Rejection 65 65
Unintended Deflation 62 62
Failure to Deflate 61 61
Material Erosion 60 60
Migration or Expulsion of Device 56 56
Material Frayed 54 54
Missing Information 49 49
Connection Problem 49 49
Use of Device Problem 47 47
Material Twisted/Bent 46 46
Crack 45 45
No Apparent Adverse Event 44 44
Material Protrusion/Extrusion 41 41
Difficult or Delayed Activation 41 41
Self-Activation or Keying 38 38
Free or Unrestricted Flow 32 32
Infusion or Flow Problem 30 30
Mechanical Jam 23 23
Device Contamination with Chemical or Other Material 22 22
Patient Device Interaction Problem 22 22
Material Discolored 21 21
Patient-Device Incompatibility 21 21
Noise, Audible 19 19
Material Rupture 18 18
Device Dislodged or Dislocated 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10832 10832
No Known Impact Or Consequence To Patient 1741 1741
Unspecified Infection 1577 1577
No Consequences Or Impact To Patient 1071 1071
Pain 875 875
Erosion 813 813
Insufficient Information 506 506
Discomfort 468 468
Perforation 279 279
Failure of Implant 212 212
Bacterial Infection 203 203
Swelling/ Edema 157 157
No Information 136 136
Scar Tissue 109 109
Capsular Contracture 99 99
Wound Dehiscence 94 94
Adhesion(s) 86 86
Hematoma 84 84
Inflammation 80 80
Purulent Discharge 73 73
Skin Erosion 62 62
Deformity/ Disfigurement 62 62
Unspecified Tissue Injury 59 59
Hernia 58 58
Complaint, Ill-Defined 43 43
Fluid Discharge 33 33
Hemorrhage/Bleeding 32 32
Fibrosis 27 27
Swelling 25 25
Depression 22 22
Impaired Healing 21 21
Tissue Damage 20 20
Fever 20 20
Urinary Retention 20 20
Anxiety 19 19
Dysuria 19 19
Numbness 18 18
Abdominal Pain 17 17
Fistula 17 17
Abscess 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Urinary Tract Infection 16 16
No Code Available 16 16
Erectile Dysfunction 15 15
Post Operative Wound Infection 14 14
Hypersensitivity/Allergic reaction 14 14
Burning Sensation 13 13
Urinary Incontinence 13 13
Aneurysm 12 12
Skin Inflammation/ Irritation 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Apr-12-2023
2 Coloplast Manufacturing US, LLC II Dec-22-2021
3 Coloplast Manufacturing US, LLC II Nov-25-2020
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