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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 57

MDR Year MDR Reports MDR Events
2019 1272 1272
2020 1155 1155
2021 1422 1422
2022 1358 1358
2023 1478 1478
2024 901 918

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5927 5944
Improper or Incorrect Procedure or Method 906 906
Off-Label Use 309 309
Patient-Device Incompatibility 124 124
Use of Device Problem 90 90
Insufficient Information 64 64
Detachment of Device or Device Component 57 57
Gel Leak 53 53
Migration 36 36
No Apparent Adverse Event 30 30
Device Appears to Trigger Rejection 29 29
Break 23 23
Migration or Expulsion of Device 20 20
Crack 17 17
Output Problem 14 14
Patient Device Interaction Problem 13 13
Difficult or Delayed Activation 11 11
Product Quality Problem 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
Human-Device Interface Problem 3 3
Contamination 3 3
Positioning Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination of Device Ingredient or Reagent 3 3
Device Handling Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Material Fragmentation 2 2
Expiration Date Error 2 2
Defective Device 2 2
Device Contamination with Chemical or Other Material 2 2
Expulsion 2 2
Device Ingredient or Reagent Problem 2 2
Missing Information 2 2
Retraction Problem 1 1
Device Markings/Labelling Problem 1 1
Excess Flow or Over-Infusion 1 1
Device Slipped 1 1
Fluid/Blood Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Ejection Problem 1 1
Dull, Blunt 1 1
Loose or Intermittent Connection 1 1
Air/Gas in Device 1 1
Contamination /Decontamination Problem 1 1
Biofilm coating in Device 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nodule 943 943
Inflammation 943 943
Obstruction/Occlusion 922 922
Unspecified Infection 883 883
Skin Irritation 718 718
Abscess 590 590
Subcutaneous Nodule 430 430
Swelling/ Edema 387 387
Edema 373 373
Pain 338 338
Hypersensitivity/Allergic reaction 320 320
Granuloma 319 319
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 308 309
Necrosis 285 285
Vascular System (Circulation), Impaired 284 284
Erythema 233 233
No Code Available 228 228
Foreign Body Embolism 187 187
Viral Infection 182 182
Swelling 152 152
Skin Discoloration 149 149
Cellulitis 131 131
Bacterial Infection 121 124
Skin Inflammation/ Irritation 108 108
Skin Infection 106 106
Bruise/Contusion 99 99
No Consequences Or Impact To Patient 97 97
Ischemia 97 97
Foreign Body Reaction 90 90
Respiratory Tract Infection 84 84
Purulent Discharge 75 75
Urinary Tract Infection 74 74
Swollen Lymph Nodes/Glands 72 72
Deformity/ Disfigurement 71 71
Loss of Vision 62 62
Injection Site Reaction 61 61
Implant Pain 59 59
Pallor 57 57
Fluid Discharge 54 54
No Clinical Signs, Symptoms or Conditions 52 52
Angioedema 51 51
Embolism/Embolus 49 49
Occlusion 49 49
Autoimmune Disorder 43 43
Blurred Vision 43 43
Anaphylactic Shock 41 41
Headache 40 40
Discomfort 39 39
Hematoma 37 38
Visual Impairment 36 36

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