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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
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)
2019 2020 2021 2022 2023 2024
3 4 2 3 3 2

MDR Year MDR Reports MDR Events
2019 4010 4010
2020 3562 3562
2021 3720 3720
2022 3203 3203
2023 3675 3675
2024 2820 2820

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4627 4627
Fluid/Blood Leak 4315 4315
Inflation Problem 3888 3888
Adverse Event Without Identified Device or Use Problem 3629 3629
Material Puncture/Hole 2854 2854
Insufficient Information 2141 2141
Migration 1280 1280
Fracture 1169 1169
Inadequacy of Device Shape and/or Size 890 890
Defective Device 754 754
Collapse 750 750
Deflation Problem 723 723
Break 688 688
Malposition of Device 545 545
Pumping Problem 457 457
Degraded 421 421
Leak/Splash 360 360
Material Deformation 218 218
Appropriate Term/Code Not Available 214 214
Failure to Cycle 191 191
Material Split, Cut or Torn 107 107
Positioning Problem 97 97
Air/Gas in Device 93 93
Use of Device Problem 91 91
Physical Resistance/Sticking 81 81
Migration or Expulsion of Device 70 70
Device Appears to Trigger Rejection 68 68
Failure to Pump 65 65
Material Erosion 60 60
Crack 58 58
Free or Unrestricted Flow 56 56
Unintended Deflation 55 55
Material Protrusion/Extrusion 55 55
Connection Problem 53 53
Material Twisted/Bent 53 53
Infusion or Flow Problem 50 50
Failure to Deflate 49 49
Missing Information 49 49
Material Frayed 44 44
No Apparent Adverse Event 42 42
Difficult or Delayed Activation 40 40
Mechanical Jam 34 34
Self-Activation or Keying 28 28
Device Contamination with Chemical or Other Material 23 23
Material Discolored 23 23
Noise, Audible 22 22
Patient Device Interaction Problem 22 22
Device Dislodged or Dislocated 18 18
Device Contaminated During Manufacture or Shipping 18 18
Material Rupture 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9753 9753
No Known Impact Or Consequence To Patient 3666 3666
Unspecified Infection 1801 1801
No Consequences Or Impact To Patient 1667 1667
Pain 985 985
Erosion 902 902
No Information 824 824
Insufficient Information 507 507
Discomfort 484 484
Perforation 301 301
Bacterial Infection 207 207
Failure of Implant 202 202
Swelling/ Edema 149 149
Scar Tissue 116 116
Capsular Contracture 114 114
Wound Dehiscence 105 105
Hematoma 92 92
Complaint, Ill-Defined 88 88
Adhesion(s) 86 86
Inflammation 85 85
Purulent Discharge 71 71
Skin Erosion 62 62
Hernia 57 57
Fluid Discharge 49 49
Unspecified Tissue Injury 48 48
Swelling 47 47
Tissue Damage 44 44
Deformity/ Disfigurement 40 40
Hemorrhage/Bleeding 35 35
Fibrosis 25 25
Scarring 25 25
No Code Available 24 24
Urinary Retention 24 24
Impaired Healing 24 24
Dysuria 23 23
Fever 23 23
Depression 21 21
Abscess 21 21
Hypersensitivity/Allergic reaction 20 20
Fistula 19 19
Urinary Tract Infection 18 18
Injury 18 18
Anxiety 18 18
Abdominal Pain 18 18
Aneurysm 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Numbness 15 15
Impotence 15 15
Post Operative Wound Infection 15 15
Burning Sensation 13 13

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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