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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue expander and accessories
Product CodeLCJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
MENTOR WORLDWIDE, LLC
  SUBSTANTIALLY EQUIVALENT 3
MOTIVA, USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIENTRA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 440 444
2022 499 518
2023 473 478
2024 488 489
2025 500 501

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 967 973
Adverse Event Without Identified Device or Use Problem 574 575
Fluid/Blood Leak 331 335
Device Appears to Trigger Rejection 126 126
Break 72 73
Off-Label Use 45 45
Patient-Device Incompatibility 40 48
Migration 37 37
Deflation Problem 37 37
No Apparent Adverse Event 35 35
Device Handling Problem 31 31
Defective Device 25 25
Device Contaminated During Manufacture or Shipping 23 23
Use of Device Problem 23 23
Appropriate Term/Code Not Available 21 21
Improper or Incorrect Procedure or Method 19 19
Connection Problem 18 18
Infusion or Flow Problem 17 17
Leak/Splash 14 14
Difficult to Open or Remove Packaging Material 13 13
Peeled/Delaminated 13 13
Product Quality Problem 13 13
Unintended Deflation 12 13
Device Contamination with Chemical or Other Material 10 10
Detachment of Device or Device Component 8 8
Communication or Transmission Problem 7 7
Filling Problem 7 7
Insufficient Information 7 8
Material Deformation 7 7
Malposition of Device 6 6
Component Missing 6 6
Packaging Problem 4 4
Shipping Damage or Problem 4 4
Unsealed Device Packaging 4 4
Device Damaged Prior to Use 4 4
Material Discolored 3 3
Patient Device Interaction Problem 3 3
Material Integrity Problem 3 3
Expiration Date Error 3 3
Nonstandard Device 3 9
Inflation Problem 2 2
Material Separation 2 2
Defective Component 2 2
Device Dislodged or Dislocated 2 2
Material Puncture/Hole 2 2
Gel Leak 2 5
Collapse 2 2
Device-Device Incompatibility 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 794 795
Failure of Implant 461 466
No Clinical Signs, Symptoms or Conditions 280 280
Unspecified Infection 245 246
Seroma 155 158
Capsular Contracture 152 155
Post Operative Wound Infection 134 134
Necrosis 83 86
Insufficient Information 65 65
Breast Discomfort/Pain 38 42
Wound Dehiscence 36 37
Impaired Healing 35 38
Hematoma 34 34
Bacterial Infection 33 40
Foreign Body Reaction 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 32
Pain 29 41
Rupture 24 25
Cellulitis 23 23
Local Reaction 21 21
Erythema 18 24
Swollen Lymph Nodes/Glands 15 15
Lymphoma 14 14
Pocket Erosion 14 14
Swelling/ Edema 14 26
Hypersensitivity/Allergic reaction 13 13
Erosion 12 12
Fluid Discharge 11 14
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 10 10
Cancer 9 12
Wrinkling 9 9
Inflammation 9 16
Autoimmune Disorder 8 8
Scar Tissue 8 12
Fatigue 8 18
Rash 7 15
Burning Sensation 6 15
Unspecified Tissue Injury 6 6
Breast Cancer 6 6
Weight Changes 5 12
Arthralgia 5 10
Emotional Changes 5 5
Myalgia 5 12
Abscess 5 5
Chest Pain 4 12
Discomfort 4 4
Depression 4 5
Numbness 4 10
Fever 4 9
Paresthesia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Nov-03-2023
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