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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, breast, inflatable, internal, saline
Regulation Description Silicone inflatable breast prosthesis.
Definition Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Product CodeFWM
Regulation Number 878.3530
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
7 9 4 6 7 0

MDR Year MDR Reports MDR Events
2020 14021 14021
2021 11351 11351
2022 13654 13654
2023 11012 11012
2024 9944 9952
2025 771 771

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 22175 22175
Material Rupture 22082 22082
Adverse Event Without Identified Device or Use Problem 9232 9232
Device Appears to Trigger Rejection 5609 5609
Patient-Device Incompatibility 1459 1459
Deflation Problem 1162 1162
Migration 631 631
No Apparent Adverse Event 388 388
Insufficient Information 275 275
Appropriate Term/Code Not Available 173 173
Unintended Deflation 152 160
Peeled/Delaminated 142 142
Detachment of Device or Device Component 115 115
Device Handling Problem 95 95
Off-Label Use 79 79
Connection Problem 69 69
Use of Device Problem 66 66
Break 65 65
Microbial Contamination of Device 61 61
Patient Device Interaction Problem 48 48
Improper or Incorrect Procedure or Method 43 43
Loss of or Failure to Bond 41 41
Gel Leak 39 39
Failure to Fold 30 30
Defective Device 28 28
Material Split, Cut or Torn 27 27
Nonstandard Device 25 25
Material Perforation 24 24
Device Contamination with Chemical or Other Material 22 22
Difficult to Open or Remove Packaging Material 22 22
Air/Gas in Device 20 20
Material Deformation 19 19
Burst Container or Vessel 15 15
Material Discolored 15 15
Short Fill 13 13
Defective Component 13 13
Material Invagination 9 9
Malposition of Device 9 9
Material Integrity Problem 7 7
Device Dislodged or Dislocated 6 6
Infusion or Flow Problem 6 6
Device Damaged Prior to Use 6 6
Leak/Splash 6 6
Device Contaminated During Manufacture or Shipping 6 6
Contamination of Device Ingredient or Reagent 6 6
Contamination /Decontamination Problem 5 5
Migration or Expulsion of Device 5 5
Unsealed Device Packaging 5 5
Delivered as Unsterile Product 4 4
Tear, Rip or Hole in Device Packaging 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 26718 26726
Deformity/ Disfigurement 12070 12070
Capsular Contracture 11132 11132
No Code Available 4587 4587
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1644 1644
Seroma 1209 1209
Pain 1177 1177
No Clinical Signs, Symptoms or Conditions 1066 1066
Breast Discomfort/Pain 858 858
Insufficient Information 678 678
Unspecified Infection 550 550
Autoimmune Disorder 460 460
Swollen Lymph Nodes/Glands 437 437
Wrinkling 417 417
Breast Mass 327 327
Lymphoma 323 323
Fatigue 205 205
Autoimmune Reaction 187 187
Post Operative Wound Infection 180 180
Local Reaction 179 179
No Known Impact Or Consequence To Patient 170 170
Paresthesia 158 158
Crushing Injury 146 146
Swollen Lymph Nodes 144 144
Anxiety 133 133
Cancer 130 130
Injury 129 129
Headache 126 126
Hair Loss 122 122
Inflammation 120 120
Cyst(s) 118 118
Granuloma 109 109
Depression 107 107
Arthralgia 105 105
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 98 98
Calcium Deposits/Calcification 97 97
Rash 97 97
Skin Inflammation/ Irritation 94 94
Cognitive Changes 86 86
Hypersensitivity/Allergic reaction 82 82
Impaired Healing 80 80
Necrosis 75 75
Neurological Deficit/Dysfunction 75 75
Weight Changes 74 74
Wound Dehiscence 72 72
Memory Loss/Impairment 69 69
Sleep Dysfunction 69 69
Dyspnea 67 67
Foreign Body Reaction 59 59
Dry Eye(s) 58 58

Recalls
Manufacturer Recall Class Date Posted
1 Mentor Texas, LP. II Dec-10-2021
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