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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device tissue expander and accessories
Product CodeLCJ
Device Class Unclassified


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

MDR Year MDR Reports MDR Events
2020 639 639
2021 438 438
2022 499 499
2023 478 478
2024 490 490
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 1102 1102
Adverse Event Without Identified Device or Use Problem 580 580
Fluid/Blood Leak 379 379
Device Appears to Trigger Rejection 114 114
Off-Label Use 74 74
Break 64 64
Patient-Device Incompatibility 48 48
Deflation Problem 40 40
Migration 34 34
Defective Device 34 34
Improper or Incorrect Procedure or Method 28 28
Device Handling Problem 27 27
Connection Problem 21 21
Use of Device Problem 21 21
Device Contamination with Chemical or Other Material 17 17
Appropriate Term/Code Not Available 16 16
Infusion or Flow Problem 15 15
Device Contaminated During Manufacture or Shipping 15 15
No Apparent Adverse Event 13 13
Difficult to Open or Remove Packaging Material 10 10
Leak/Splash 9 9
Filling Problem 9 9
Defective Component 9 9
Unintended Deflation 9 9
Peeled/Delaminated 9 9
Inflation Problem 8 8
Detachment of Device or Device Component 7 7
Material Deformation 6 6
Component Missing 6 6
Material Separation 5 5
Packaging Problem 5 5
Material Integrity Problem 4 4
Shipping Damage or Problem 4 4
Unsealed Device Packaging 4 4
Nonstandard Device 4 4
Expiration Date Error 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 3 3
Biofilm coating in Device 2 2
Device-Device Incompatibility 2 2
Material Puncture/Hole 2 2
Material Discolored 2 2
Device Damaged Prior to Use 2 2
Device Dislodged or Dislocated 2 2
Gel Leak 2 2
Collapse 2 2
Expulsion 1 1
Contamination /Decontamination Problem 1 1
Solder Joint Fracture 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 664 664
Failure of Implant 482 482
No Code Available 299 299
Unspecified Infection 277 277
No Clinical Signs, Symptoms or Conditions 215 215
Seroma 164 164
Capsular Contracture 144 144
Post Operative Wound Infection 105 105
Necrosis 77 77
Insufficient Information 64 64
No Consequences Or Impact To Patient 48 48
Wound Dehiscence 43 43
No Patient Involvement 40 40
Pain 35 35
Hematoma 34 35
Foreign Body Reaction 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Breast Discomfort/Pain 27 27
Impaired Healing 26 26
Local Reaction 23 23
No Known Impact Or Consequence To Patient 21 21
Cellulitis 21 21
Rupture 19 19
Bacterial Infection 19 19
Lymphoma 17 17
Pocket Erosion 15 15
Swollen Lymph Nodes/Glands 15 15
Erythema 15 15
Cancer 13 13
Erosion 11 11
Swelling/ Edema 10 10
Hypersensitivity/Allergic reaction 10 10
Inflammation 10 10
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 10 10
Wrinkling 9 9
Fluid Discharge 9 9
Fatigue 8 8
Unspecified Tissue Injury 8 8
Fever 7 7
Autoimmune Disorder 7 7
Scar Tissue 6 6
Myalgia 6 6
Breast Cancer 6 6
Arthralgia 5 5
Memory Loss/Impairment 5 5
Rash 5 5
Abscess 5 5
Hemorrhage/Bleeding 4 4
Burning Sensation 4 4
Numbness 4 4

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