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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 2

MDR Year MDR Reports MDR Events
2020 3562 3562
2021 3719 3721
2022 3203 3212
2023 3675 3676
2024 4082 4082
2025 2360 2396

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4540 4541
Mechanical Problem 4484 4516
Adverse Event Without Identified Device or Use Problem 4017 4028
Inflation Problem 3806 3807
Material Puncture/Hole 2858 2859
Fracture 1566 1566
Insufficient Information 1313 1319
Migration 1254 1278
Inadequacy of Device Shape and/or Size 953 953
Collapse 696 696
Deflation Problem 695 695
Malposition of Device 624 624
Defective Device 570 570
Pumping Problem 447 447
Break 431 431
Degraded 368 368
Material Deformation 223 223
Appropriate Term/Code Not Available 212 212
Leak/Splash 191 191
Air/Gas in Device 138 138
Physical Resistance/Sticking 120 120
Failure to Pump 105 105
Failure to Cycle 95 95
Device Appears to Trigger Rejection 95 95
Failure to Deflate 90 90
Material Split, Cut or Torn 89 89
Positioning Problem 79 79
Unintended Deflation 77 77
Material Frayed 70 70
Self-Activation or Keying 64 64
Material Erosion 62 62
Migration or Expulsion of Device 56 56
Connection Problem 54 54
Missing Information 49 49
Use of Device Problem 48 49
No Apparent Adverse Event 48 48
Material Twisted/Bent 47 47
Crack 45 45
Difficult or Delayed Activation 41 41
Material Protrusion/Extrusion 41 41
Free or Unrestricted Flow 32 32
Infusion or Flow Problem 30 30
Disconnection 28 28
Material Rupture 26 26
Device Contamination with Chemical or Other Material 24 24
Device Damaged by Another Device 24 24
Mechanical Jam 24 24
Patient Device Interaction Problem 22 22
Patient-Device Incompatibility 22 22
Material Discolored 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12492 12532
Unspecified Infection 1777 1784
No Known Impact Or Consequence To Patient 1741 1741
No Consequences Or Impact To Patient 1071 1071
Pain 963 964
Erosion 944 944
Insufficient Information 514 514
Discomfort 509 509
Perforation 295 295
Failure of Implant 217 217
Bacterial Infection 205 205
Swelling/ Edema 177 177
No Information 136 136
Scar Tissue 115 115
Capsular Contracture 106 106
Hematoma 97 97
Wound Dehiscence 97 97
Adhesion(s) 95 95
Purulent Discharge 87 87
Inflammation 83 83
Unspecified Tissue Injury 82 82
Deformity/ Disfigurement 81 81
Hernia 64 64
Skin Erosion 62 62
Complaint, Ill-Defined 43 43
Hemorrhage/Bleeding 36 36
Fluid Discharge 34 34
Fibrosis 34 34
Swelling 25 25
Urinary Retention 23 23
Abscess 22 22
Depression 22 22
Impaired Healing 22 22
Fever 22 22
Dysuria 21 21
Numbness 21 21
Tissue Damage 20 20
Anxiety 20 21
Fistula 17 17
Erectile Dysfunction 17 17
Abdominal Pain 17 17
Urinary Incontinence 16 16
No Code Available 16 16
Urinary Tract Infection 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Burning Sensation 16 16
Post Operative Wound Infection 16 21
Hypersensitivity/Allergic reaction 15 15
Sexual Dysfunction 13 13
Aneurysm 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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