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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, dermal, for aesthetic use
Product CodeLMH
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
51 40 81 74 51 22

MDR Year MDR Reports MDR Events
2021 1422 1422
2022 1358 1378
2023 1478 1479
2024 1372 1393
2025 1825 1825
2026 585 585

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5975 6009
Improper or Incorrect Procedure or Method 1211 1212
Off-Label Use 773 773
Use of Device Problem 119 119
No Apparent Adverse Event 111 111
Insufficient Information 93 93
Patient-Device Incompatibility 86 87
Device Appears to Trigger Rejection 50 50
Migration 33 34
Patient Device Interaction Problem 29 30
Appropriate Term/Code Not Available 15 15
Output Problem 15 15
Therapeutic or Diagnostic Output Failure 8 8
Product Quality Problem 7 9
Biofilm coating in Device 5 5
Use of Incorrect Control/Treatment Settings 5 5
Defective Device 5 7
Nonstandard Device 4 4
Unexpected Therapeutic Results 4 4
Malposition of Device 3 3
Expiration Date Error 3 3
Device Ingredient or Reagent Problem 3 3
Human-Device Interface Problem 3 3
Missing Information 2 2
Positioning Problem 2 2
Detachment of Device or Device Component 2 2
Delivered as Unsterile Product 2 4
Contamination 2 2
Material Fragmentation 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Gel Leak 1 1
Excess Flow or Over-Infusion 1 1
Fluid/Blood Leak 1 1
Material Too Rigid or Stiff 1 1
Device Slipped 1 1
Output below Specifications 1 1
Misassembly by Users 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Air/Gas in Device 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nodule 1634 1635
Obstruction/Occlusion 1332 1332
Unspecified Infection 683 685
Inflammation 674 674
Abscess 660 661
Subcutaneous Nodule 616 616
Swelling/ Edema 512 516
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 396 398
Granuloma 329 329
Hypersensitivity/Allergic reaction 329 330
No Clinical Signs, Symptoms or Conditions 245 245
Necrosis 242 242
Foreign Body Embolism 238 238
Viral Infection 190 190
Skin Infection 149 149
Skin Inflammation/ Irritation 147 147
Pain 136 147
Bacterial Infection 128 131
Cellulitis 126 126
Local Reaction 104 104
Skin Discoloration 98 101
Erythema 96 96
Injection Site Reaction 92 92
Swollen Lymph Nodes/Glands 81 82
Ischemia 81 81
Respiratory Tract Infection 78 78
Deformity/ Disfigurement 76 78
Implant Pain 75 75
Angioedema 71 72
Urinary Tract Infection 69 69
Fluid Discharge 62 62
Autoimmune Disorder 58 58
Foreign Body Reaction 58 58
Loss of Vision 52 54
Embolism/Embolus 49 49
Purulent Discharge 44 44
Anaphylactic Shock 44 44
Bruise/Contusion 42 42
Blurred Vision 42 42
Dyspnea 38 38
Skin Erosion 37 37
Discomfort 33 33
Cancer 32 32
Deposits 31 31
Scar Tissue 31 31
Visual Disturbances 31 31
Pallor 30 30
Hematoma 29 30
Headache 28 29
Visual Impairment 28 28

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