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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, anti-gastroesophageal reflux
Product CodeLEI
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 3 5 3 4 4 1 6 2 1 0 6 2 1

MDR Year MDR Reports MDR Events
2014 42 42
2015 57 57
2016 92 92
2017 133 133
2018 202 202
2019 280 280
2020 193 193
2021 263 263
2022 250 250
2023 246 246
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1024 1024
Device Appears to Trigger Rejection 549 549
Patient Device Interaction Problem 329 329
Detachment of Device or Device Component 186 186
Migration or Expulsion of Device 148 148
Appropriate Term/Code Not Available 111 111
Insufficient Information 67 67
Therapeutic or Diagnostic Output Failure 42 42
Unexpected Therapeutic Results 21 21
Material Erosion 18 18
Patient-Device Incompatibility 17 17
Device-Device Incompatibility 13 13
Nonstandard Device 13 13
Defective Component 9 9
Material Separation 8 8
Break 7 7
Use of Device Problem 6 6
Disconnection 4 4
Improper or Incorrect Procedure or Method 4 4
Malposition of Device 4 4
Protective Measures Problem 3 3
Migration 3 3
Device Operates Differently Than Expected 2 2
Mechanical Problem 2 2
Obstruction of Flow 1 1
Scratched Material 1 1
Structural Problem 1 1
Device Damaged by Another Device 1 1
Delivered as Unsterile Product 1 1
High Test Results 1 1
Material Deformation 1 1
Contamination /Decontamination Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
No Apparent Adverse Event 1 1
Difficult to Remove 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Device Slipped 1 1
Fluid/Blood Leak 1 1
Hole In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dysphagia/ Odynophagia 1043 1043
No Code Available 460 460
Pyrosis/Heartburn 422 422
Insufficient Information 193 193
Pain 191 191
Vomiting 163 163
Hernia 114 114
Nausea 72 72
Erosion 69 69
Pocket Erosion 67 67
Abdominal Pain 60 60
Chest Pain 48 48
Cramp(s) /Muscle Spasm(s) 41 41
Abdominal Distention 38 38
Weight Changes 36 36
Inflammation 32 32
No Consequences Or Impact To Patient 25 25
No Information 23 23
No Known Impact Or Consequence To Patient 19 19
Paresis 19 19
Foreign Body In Patient 13 13
Anxiety 12 12
Muscle Spasm(s) 11 11
Discomfort 11 11
Not Applicable 10 10
Choking 9 9
Diarrhea 8 8
Failure of Implant 8 8
Pneumonia 8 8
Obstruction/Occlusion 8 8
Adhesion(s) 8 8
Regurgitation 8 8
Scar Tissue 8 8
Burning Sensation 7 7
Complaint, Ill-Defined 7 7
No Clinical Signs, Symptoms or Conditions 7 7
High Blood Pressure/ Hypertension 7 7
Unspecified Infection 6 6
Headache 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Speech Disorder 6 6
Dehydration 5 5
Fatigue 5 5
Flatus 5 5
Perforation of Esophagus 4 4
Hypersensitivity/Allergic reaction 4 4
Abscess 4 4
Autoimmune Disorder 4 4
Pneumothorax 3 3
Blood Loss 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Torax Medical, Inc. II May-31-2018
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