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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)
2017 2018 2019 2020 2021 2022
52 57 68 61 51 2

MDR Year MDR Reports MDR Events
2017 1508 1508
2018 1801 1801
2019 1272 1272
2020 1155 1155
2021 1422 1422

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4978 4978
Improper or Incorrect Procedure or Method 469 469
Detachment of Device or Device Component 431 431
Detachment Of Device Component 376 376
Gel Leak 305 305
Expulsion 236 236
Crack 203 203
Break 196 196
Leak/Splash 195 195
Off-Label Use 143 143
Patient-Device Incompatibility 128 128
Burst Container or Vessel 73 73
Migration or Expulsion of Device 51 51
Migration 49 49
Difficult or Delayed Positioning 48 48
Difficult or Delayed Activation 40 40
Use of Device Problem 30 30
Insufficient Information 30 30
Defective Component 26 26
Coagulation in Device or Device Ingredient 13 13
Product Quality Problem 10 10
Shelf Life Exceeded 10 10
Patient Device Interaction Problem 10 10
Device Operates Differently Than Expected 9 9
Unintended Ejection 8 8
Fracture 7 7
Clumping in Device or Device Ingredient 7 7
Loose or Intermittent Connection 6 6
Difficult to Remove 6 6
Device Contamination with Chemical or Other Material 6 6
Output Problem 6 6
Fitting Problem 5 5
Device Appears to Trigger Rejection 5 5
Occlusion Within Device 5 5
Bent 5 5
Material Too Rigid or Stiff 4 4
Material Rupture 4 4
Infusion or Flow Problem 4 4
Malposition of Device 4 4
Contamination of Device Ingredient or Reagent 4 4
Appropriate Term/Code Not Available 4 4
Positioning Problem 4 4
Device Handling Problem 3 3
Activation, Positioning or SeparationProblem 3 3
Material Deformation 3 3
Material Integrity Problem 3 3
Device Ingredient or Reagent Problem 3 3
Defective Device 3 3
Partial Blockage 3 3
Positioning Failure 2 2
Contamination 2 2
Particulates 2 2
Material Opacification 2 2
Delivered as Unsterile Product 2 2
Physical Resistance 2 2
Dull, Blunt 2 2
Short Fill 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Connection Problem 2 2
Device Dislodged or Dislocated 2 2
Human-Device Interface Problem 2 2
Improper Flow or Infusion 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Pressure Problem 1 1
Noise, Audible 1 1
Overcorrection 1 1
Explosion 1 1
Ejection Problem 1 1
Missing Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Chemical Spillage 1 1
Contamination /Decontamination Problem 1 1
Delivery System Failure 1 1
Incomplete or Missing Packaging 1 1
Fungus in Device Environment 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Obstruction of Flow 1 1
Unsealed Device Packaging 1 1
Material Separation 1 1
Retraction Problem 1 1
Use of Incorrect Control Settings 1 1
Degraded 1 1
Disassembly 1 1
Disconnection 1 1
Component Falling 1 1
Biofilm coating in Device 1 1
Backflow 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 1559 1559
Inflammation 1247 1247
Edema 1084 1084
Unspecified Infection 786 786
No Known Impact Or Consequence To Patient 732 732
Pain 609 609
No Consequences Or Impact To Patient 531 531
Vascular System (Circulation), Impaired 519 519
Erythema 381 381
Hypersensitivity/Allergic reaction 357 357
No Code Available 351 351
Skin Discoloration 318 318
Subcutaneous Nodule 291 291
Necrosis 287 287
Abscess 278 278
Granuloma 271 271
Obstruction/Occlusion 259 259
Swelling 239 239
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 181 181
Bruise/Contusion 170 170
Swelling/ Edema 161 161
Cellulitis 119 119
Ischemia 102 102
Foreign Body Reaction 95 95
Skin Inflammation 95 95
Viral Infection 89 89
Scarring 83 83
Purulent Discharge 79 79
Bacterial Infection 79 79
Occlusion 75 75
Loss of Vision 73 73
Foreign Body Embolism 69 69
Headache 68 68
Rash 65 65
Visual Impairment 57 57
Pallor 57 57
Itching Sensation 56 56
Anxiety 54 54
Deformity/ Disfigurement 53 53
Patient Problem/Medical Problem 50 50
Complaint, Ill-Defined 49 49
Skin Inflammation/ Irritation 49 49
Numbness 48 48
Hematoma 47 47
Fever 41 41
Nodule 41 41
Dyspnea 40 40
Discomfort 37 37
Respiratory Tract Infection 36 36
No Patient Involvement 36 36
Blurred Vision 35 35
Anaphylactic Shock 35 35
Cyst(s) 33 33
Implant Pain 33 33
Injection Site Reaction 31 31
Autoimmune Reaction 29 29
Embolism 29 29
Autoimmune Disorder 28 28
Nausea 28 28
Cytomegalovirus (CMV) Infection 28 28
Reaction 28 28
Urticaria 27 27
Urinary Tract Infection 27 27
Scar Tissue 26 26
Ecchymosis 26 26
Skin Infection 26 26
Irritation 25 25
Dizziness 25 25
Depression 24 24
Unspecified Vascular Problem 24 24
Swollen Lymph Nodes/Glands 23 23
Fluid Discharge 22 22
Peeling 22 22
Hemorrhage/Bleeding 20 20
Ptosis 20 20
Fibrosis 20 20
Tingling 20 20
Malaise 19 19
Swollen Lymph Nodes 19 19
Visual Disturbances 18 18
Discharge 18 18
Tissue Damage 16 16
Facial Nerve Paralysis 16 16
Ulcer 15 15
Angioedema 15 15
Stroke/CVA 14 14
Paralysis 14 14
Easy Bruising 13 13
Vomiting 13 13
Burning Sensation 13 13
Fatigue 12 12
Dysphagia/ Odynophagia 12 12
Eye Injury 11 11
Herpes 11 11
Hyperemia 11 11
Blood Loss 11 11
Nerve Damage 10 10
Skin Erosion 9 9
Pneumonia 9 9
Vertigo 9 9

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