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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, breast, noninflatable, internal, silicone gel-filled
Definition Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Product CodeFTR
Regulation Number 878.3540
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
14 10 21 8 10 5

MDR Year MDR Reports MDR Events
2019 21378 21378
2020 24290 24290
2021 23355 23355
2022 30809 30809
2023 29089 29092
2024 14994 14994

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 63816 63816
Adverse Event Without Identified Device or Use Problem 37629 37629
Device Appears to Trigger Rejection 29349 29352
Patient-Device Incompatibility 14042 14042
Patient Device Interaction Problem 3447 3447
Migration 3116 3116
Gel Leak 1843 1843
Appropriate Term/Code Not Available 1176 1176
No Apparent Adverse Event 556 556
Off-Label Use 280 280
Fluid/Blood Leak 263 263
Device Handling Problem 252 252
Material Deformation 197 197
Break 195 195
Material Discolored 184 184
Malposition of Device 171 171
Use of Device Problem 163 163
Insufficient Information 124 124
Improper or Incorrect Procedure or Method 109 109
Device Contamination with Chemical or Other Material 89 89
Nonstandard Device 80 80
Difficult to Open or Remove Packaging Material 56 56
Defective Device 54 54
Leak/Splash 50 50
Migration or Expulsion of Device 48 48
Device Dislodged or Dislocated 45 45
Material Protrusion/Extrusion 43 43
Air/Gas in Device 42 42
Positioning Failure 34 34
Biocompatibility 33 33
Delivered as Unsterile Product 32 32
Device Contaminated During Manufacture or Shipping 28 28
Short Fill 27 27
Microbial Contamination of Device 26 26
Material Integrity Problem 23 23
Positioning Problem 23 23
Material Invagination 21 24
Unsealed Device Packaging 20 20
Inadequacy of Device Shape and/or Size 19 19
Deflation Problem 18 18
Peeled/Delaminated 17 17
Unintended Deflation 17 17
Device Damaged Prior to Use 14 14
Shipping Damage or Problem 14 14
Contamination 13 13
Biofilm coating in Device 13 13
Product Quality Problem 12 12
Defective Component 9 9
Volume Accuracy Problem 8 8
Structural Problem 8 8
Loss of or Failure to Bond 8 8
Output Problem 8 8
Unintended Movement 6 6
Noise, Audible 6 6
Material Split, Cut or Torn 6 6
Contamination /Decontamination Problem 6 6
Deformation Due to Compressive Stress 4 4
Fungus in Device Environment 4 4
Material Too Rigid or Stiff 4 4
Burst Container or Vessel 4 4
Material Disintegration 4 4
Fracture 4 4
Packaging Problem 4 4
Device Markings/Labelling Problem 3 3
Inaccurate Information 3 3
Material Puncture/Hole 3 3
Unintended Ejection 3 3
Contamination of Device Ingredient or Reagent 3 3
Connection Problem 2 2
Dent in Material 2 2
Material Separation 2 2
Incomplete or Missing Packaging 2 2
Labelling, Instructions for Use or Training Problem 2 2
Device Emits Odor 2 2
Melted 2 2
Degraded 2 2
Calcified 2 2
Collapse 2 2
Unexpected Color 2 2
Device Ingredient or Reagent Problem 2 2
Gas/Air Leak 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Material Twisted/Bent 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Difficult to Maintain 1 1
Optical Discoloration 1 1
Physical Resistance/Sticking 1 1
Measurement System Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expulsion 1 1
Compatibility Problem 1 1
Device-Device Incompatibility 1 1
Partial Blockage 1 1
Circuit Failure 1 1
Entrapment of Device 1 1
Particulates 1 1
Material Opacification 1 1
Material Perforation 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Contracture 71534 71537
Failure of Implant 33468 33468
Deformity/ Disfigurement 13142 13142
No Code Available 12502 12503
Seroma 7745 7745
Pain 3664 3665
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3063 3063
Unspecified Infection 2094 2094
Breast Discomfort/Pain 1845 1845
Swollen Lymph Nodes/Glands 1802 1802
Granuloma 1673 1673
No Clinical Signs, Symptoms or Conditions 1654 1654
Wrinkling 1249 1249
Rupture 1176 1176
Fatigue 1080 1081
Breast Mass 1029 1029
Insufficient Information 903 903
Autoimmune Reaction 870 870
Swollen Lymph Nodes 828 828
Local Reaction 800 800
Autoimmune Disorder 772 773
Lymphoma 766 766
Hematoma 680 680
Anxiety 623 623
Inflammation 609 612
Post Operative Wound Infection 595 595
Headache 581 582
Arthralgia 572 572
Hair Loss 546 547
Cyst(s) 473 473
Wound Dehiscence 443 443
Rash 420 421
Depression 415 415
Weight Changes 415 415
Memory Loss/Impairment 385 386
Necrosis 380 380
Impaired Healing 377 377
Cancer 367 367
Paresthesia 342 342
Cognitive Changes 342 342
Sleep Dysfunction 330 330
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 329 329
Injury 311 311
Anaplastic Large Cell Lymphoma 305 305
Hypersensitivity/Allergic reaction 288 288
Crushing Injury 282 282
Neurological Deficit/Dysfunction 267 267
Dyspnea 261 261
Numbness 256 256
Skin Inflammation/ Irritation 247 247
Swelling 220 220
Foreign Body Reaction 219 219
Pocket Erosion 219 219
Dry Eye(s) 218 218
No Known Impact Or Consequence To Patient 215 215
Palpitations 214 215
Skin Irritation 200 200
Calcium Deposits/Calcification 199 199
Confusion/ Disorientation 197 197
Chest Pain 196 196
Tinnitus 188 188
No Patient Involvement 184 184
Burning Sensation 180 180
No Consequences Or Impact To Patient 175 175
Blurred Vision 170 170
Scar Tissue 160 160
Itching Sensation 159 160
Emotional Changes 158 159
Dizziness 158 158
Vertigo 156 156
Thyroid Problems 156 156
Breast Cancer 156 156
Fluid Discharge 152 152
Swelling/ Edema 142 142
Myalgia 137 137
Sweating 134 135
Tingling 130 130
Abscess 123 123
Cellulitis 121 121
Nausea 118 118
Muscle Weakness 115 115
Complaint, Ill-Defined 105 105
Neck Pain 103 103
Bacterial Infection 99 99
Foreign Body Sensation in Eye 97 97
Fungal Infection 96 96
Malaise 95 95
Visual Impairment 95 95
Fever 90 90
Rheumatoid Arthritis 82 82
Discomfort 81 81
Increased Sensitivity 79 79
Weakness 73 73
Scarring 70 70
Urinary Tract Infection 69 69
Toxicity 69 69
Dysphagia/ Odynophagia 69 69
Arthritis 66 66
Test Result 66 66
Abdominal Distention 64 64

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC III Dec-18-2019
2 Allergan PLC I Sep-11-2019
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