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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)
2019 2020 2021 2022 2023 2024
68 61 51 40 81 19

MDR Year MDR Reports MDR Events
2019 1272 1272
2020 1155 1155
2021 1422 1422
2022 1358 1358
2023 1478 1478
2024 407 408

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5570 5571
Improper or Incorrect Procedure or Method 818 818
Off-Label Use 264 264
Patient-Device Incompatibility 124 124
Use of Device Problem 80 80
Insufficient Information 58 58
Detachment of Device or Device Component 57 57
Gel Leak 53 53
Migration 35 35
Device Appears to Trigger Rejection 28 28
No Apparent Adverse Event 25 25
Break 23 23
Migration or Expulsion of Device 20 20
Crack 17 17
Output Problem 14 14
Patient Device Interaction Problem 13 13
Product Quality Problem 11 11
Difficult or Delayed Activation 11 11
Appropriate Term/Code Not Available 8 8
Unintended Ejection 7 7
Burst Container or Vessel 6 6
Delivered as Unsterile Product 4 4
Malposition of Device 4 4
Contamination of Device Ingredient or Reagent 3 3
Contamination 3 3
Positioning Problem 3 3
Human-Device Interface Problem 3 3
Expulsion 2 2
Device Contamination with Chemical or Other Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Handling Problem 2 2
Missing Information 2 2
Use of Incorrect Control/Treatment Settings 2 2
Defective Device 2 2
Dull, Blunt 1 1
Obstruction of Flow 1 1
Biofilm coating in Device 1 1
Contamination /Decontamination Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Coagulation in Device or Device Ingredient 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Particulates 1 1
Excess Flow or Over-Infusion 1 1
Loose or Intermittent Connection 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Air/Gas in Device 1 1
Ejection Problem 1 1
Misassembly by Users 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 937 937
Nodule 827 827
Obstruction/Occlusion 826 826
Unspecified Infection 806 806
Skin Irritation 718 718
Abscess 530 530
Subcutaneous Nodule 418 418
Edema 373 373
Swelling/ Edema 363 363
Pain 333 333
Granuloma 306 306
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 300 300
Hypersensitivity/Allergic reaction 297 297
Vascular System (Circulation), Impaired 284 284
Necrosis 270 270
Erythema 230 230
No Code Available 228 228
Viral Infection 181 181
Foreign Body Embolism 170 170
Swelling 152 152
Skin Discoloration 147 147
Bacterial Infection 120 121
Cellulitis 119 119
Skin Inflammation/ Irritation 104 104
Bruise/Contusion 99 99
No Consequences Or Impact To Patient 97 97
Ischemia 91 91
Skin Infection 88 88
Foreign Body Reaction 86 86
Respiratory Tract Infection 83 83
Purulent Discharge 74 74
Urinary Tract Infection 73 73
Swollen Lymph Nodes/Glands 69 69
Deformity/ Disfigurement 64 64
Loss of Vision 62 62
Injection Site Reaction 57 57
Implant Pain 56 56
Pallor 56 56
Occlusion 49 49
Fluid Discharge 45 45
No Clinical Signs, Symptoms or Conditions 45 45
Embolism/Embolus 43 43
Blurred Vision 43 43
Angioedema 42 42
Autoimmune Disorder 42 42
Headache 40 40
Anaphylactic Shock 38 38
Discomfort 38 38
Visual Impairment 36 36
Hematoma 34 34
Scarring 33 33
Rash 32 32
Unspecified Vascular Problem 32 32
Numbness 31 31
Itching Sensation 31 31
Scar Tissue 30 30
Patient Problem/Medical Problem 30 30
Skin Inflammation 29 29
Cytomegalovirus (CMV) Infection 28 28
Skin Erosion 28 28
Fever 27 27
Dyspnea 27 27
Stroke/CVA 26 26
Nausea 24 24
Visual Disturbances 22 22
Anxiety 21 21
Ecchymosis 21 21
Urticaria 20 20
Reaction 20 20
Cyst(s) 18 18
Fibrosis 16 16
Ptosis 16 16
Cancer 16 16
Depression 15 15
Deposits 15 15
Hemorrhage/Bleeding 15 15
Paralysis 15 15
Local Reaction 15 15
Easy Bruising 15 15
Sepsis 14 14
Pneumonia 13 13
Nerve Damage 13 13
Dysphagia/ Odynophagia 13 13
Blister 13 13
Ulcer 12 12
Vomiting 12 12
Dizziness 12 12
Irritation 12 12
Swollen Lymph Nodes 12 12
Tachycardia 11 11
Hair Loss 11 11
Breast Cancer 11 11
Insufficient Information 11 11
Facial Nerve Paralysis 10 10
Fatigue 10 10
Burning Sensation 10 10
Malaise 10 10
Unspecified Eye / Vision Problem 10 10
No Known Impact Or Consequence To Patient 10 10
Paresthesia 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Prollenium Medical Technologies Inc. II Feb-11-2020
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