Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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


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

MDR Year MDR Reports MDR Events
2019 546 546
2020 639 639
2021 438 438
2022 499 499
2023 478 478
2024 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 1201 1201
Adverse Event Without Identified Device or Use Problem 595 595
Fluid/Blood Leak 429 429
Device Appears to Trigger Rejection 105 105
Off-Label Use 94 94
Patient-Device Incompatibility 61 61
Break 52 52
Improper or Incorrect Procedure or Method 46 46
Deflation Problem 43 43
Defective Device 37 37
Migration 29 29
Device Contamination with Chemical or Other Material 28 28
Use of Device Problem 28 28
Device Handling Problem 23 23
Connection Problem 21 21
Inflation Problem 19 19
Appropriate Term/Code Not Available 17 17
Defective Component 15 15
No Apparent Adverse Event 13 13
Infusion or Flow Problem 13 13
Device Contaminated During Manufacture or Shipping 12 12
Detachment of Device or Device Component 11 11
Material Separation 11 11
Leak/Splash 8 8
Unintended Deflation 8 8
Insufficient Information 7 7
Peeled/Delaminated 7 7
Filling Problem 7 7
Unsealed Device Packaging 5 5
Nonstandard Device 5 5
Material Puncture/Hole 5 5
Component Missing 5 5
Packaging Problem 5 5
Material Deformation 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Shipping Damage or Problem 4 4
Gel Leak 3 3
Material Discolored 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Expiration Date Error 3 3
Patient Device Interaction Problem 2 2
Device Damaged by Another Device 2 2
Device-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Collapse 2 2
Biofilm coating in Device 2 2
Delivered as Unsterile Product 2 2
Unintended Ejection 1 1
Fracture 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Device Contamination with Body Fluid 1 1
Solder Joint Fracture 1 1
Malposition of Device 1 1
Device Damaged Prior to Use 1 1
Expulsion 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Contamination of Device Ingredient or Reagent 1 1
Activation Failure 1 1
Incomplete or Inadequate Connection 1 1
Missing Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 577 577
Deformity/ Disfigurement 541 541
Failure of Implant 510 510
Unspecified Infection 294 294
No Clinical Signs, Symptoms or Conditions 161 161
Seroma 154 154
Capsular Contracture 153 153
Post Operative Wound Infection 86 86
No Consequences Or Impact To Patient 68 68
Necrosis 65 65
No Patient Involvement 64 64
Insufficient Information 58 58
Pain 43 43
No Known Impact Or Consequence To Patient 42 42
Wound Dehiscence 37 37
Hematoma 29 30
Foreign Body Reaction 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Cellulitis 21 21
Local Reaction 21 21
Breast Discomfort/Pain 20 20
Impaired Healing 19 19
Pocket Erosion 18 18
Bacterial Infection 15 15
Lymphoma 15 15
Swollen Lymph Nodes/Glands 14 14
Abscess 13 13
Rupture 12 12
Cancer 11 11
Fluid Discharge 10 10
Hypersensitivity/Allergic reaction 10 10
Swelling/ Edema 10 10
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 9 9
Inflammation 9 9
Erosion 9 9
Fatigue 8 8
Fever 8 8
Unspecified Tissue Injury 8 8
Scar Tissue 7 7
Wrinkling 7 7
Rash 6 6
Swelling 6 7
Itching Sensation 5 5
Memory Loss/Impairment 5 5
Erythema 5 5
Autoimmune Disorder 5 5
Autoimmune Reaction 4 4
Breast Cancer 4 4
Chest Pain 4 4
Headache 4 4
Foreign Body Sensation in Eye 4 4
Granuloma 4 4
Sepsis 4 4
Chills 4 4
Myalgia 4 4
Burning Sensation 4 4
Numbness 4 4
Arthralgia 4 4
Anxiety 4 4
Vomiting 3 3
Injury 3 3
Breast Mass 3 3
Weight Changes 3 3
Tissue Breakdown 3 3
Sleep Dysfunction 3 3
Dry Mouth 3 3
Unspecified Gastrointestinal Problem 3 3
Swollen Lymph Nodes 3 3
Skin Irritation 3 3
Nausea 3 3
Ischemia 3 3
High Blood Pressure/ Hypertension 3 3
Hemorrhage/Bleeding 3 3
Hair Loss 3 3
Diarrhea 3 3
Dry Eye(s) 3 3
Crushing Injury 3 3
Skin Disorders 3 3
Skin Inflammation/ Irritation 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Localized Skin Lesion 2 2
Cyst(s) 2 2
Pulmonary Embolism 2 2
Anemia 2 2
Dyspnea 2 2
Edema 2 2
Pyrosis/Heartburn 2 2
Muscle Weakness 2 2
Skin Discoloration 2 2
Constipation 2 2
Paresthesia 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Not Applicable 2 2
No Information 2 2
Ambulation Difficulties 2 2
Cognitive Changes 2 2
Diaphoresis 2 2
Abdominal Distention 2 2
Sweating 2 2
Depression 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC I Sep-11-2019
2 B. Braun Medical, Inc. II Nov-03-2023
-
-