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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, intragastric for morbid obesity
Product CodeLTI
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
21 5 3 2 4 2

MDR Year MDR Reports MDR Events
2019 334 334
2020 165 165
2021 193 193
2022 609 609
2023 975 975
2024 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 731 731
Deflation Problem 579 579
Fluid/Blood Leak 354 354
Adverse Event Without Identified Device or Use Problem 201 201
Unintended Deflation 185 185
Patient-Device Incompatibility 172 172
Device Slipped 159 159
Inflation Problem 99 99
Migration or Expulsion of Device 71 71
Migration 70 70
Leak/Splash 69 69
Air/Gas in Device 69 69
Material Erosion 48 48
Use of Device Problem 33 33
Detachment of Device or Device Component 18 18
Patient Device Interaction Problem 17 17
Material Separation 16 16
Break 13 13
Appropriate Term/Code Not Available 13 13
Mechanical Problem 10 10
Unintended Movement 9 9
Disconnection 8 8
Fracture 8 8
Obstruction of Flow 7 7
Output Problem 7 7
No Apparent Adverse Event 6 6
Difficult to Remove 6 6
Improper or Incorrect Procedure or Method 5 5
Therapeutic or Diagnostic Output Failure 5 5
Infusion or Flow Problem 5 5
Material Integrity Problem 5 5
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Material Twisted/Bent 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Burst Container or Vessel 4 4
Complete Blockage 3 3
Partial Blockage 3 3
Nonstandard Device 3 3
Inadequacy of Device Shape and/or Size 3 3
Premature Separation 3 3
Failure to Deflate 3 3
Compatibility Problem 3 3
Difficult to Advance 3 3
Expulsion 3 3
Material Protrusion/Extrusion 2 2
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 2 2
Component Missing 2 2
Increase in Pressure 2 2
Biofilm coating in Device 2 2
Inability to Auto-Fill 1 1
Material Disintegration 1 1
Off-Label Use 1 1
Reflux within Device 1 1
Device Appears to Trigger Rejection 1 1
Loose or Intermittent Connection 1 1
Fungus in Device Environment 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unexpected Therapeutic Results 1 1
Inadequate or Insufficient Training 1 1
Material Perforation 1 1
Defective Component 1 1
Self-Activation or Keying 1 1
Short Fill 1 1
Firing Problem 1 1
Mechanical Jam 1 1
No Flow 1 1
Misassembly by Users 1 1
Human-Device Interface Problem 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Malposition of Device 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 541 541
Vomiting 443 443
Failure of Implant 408 408
No Clinical Signs, Symptoms or Conditions 404 404
Abdominal Pain 225 225
Pain 200 200
Nausea 147 147
Erosion 137 137
Pyrosis/Heartburn 70 70
Dysphagia/ Odynophagia 61 61
Obstruction/Occlusion 61 61
No Information 55 55
Hernia 43 43
Dehydration 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
No Code Available 33 33
No Known Impact Or Consequence To Patient 28 28
Perforation 26 26
No Consequences Or Impact To Patient 24 24
Weight Changes 23 23
Ulcer 21 21
Patient Problem/Medical Problem 20 20
Scar Tissue 20 20
Unspecified Infection 20 20
Inflammation 17 17
Gastrointestinal Regurgitation 17 17
Regurgitation 17 17
Perforation of Esophagus 17 17
Sepsis 16 16
Hemorrhage/Bleeding 15 15
Discomfort 15 15
Malaise 15 15
Foreign Body In Patient 14 14
Device Embedded In Tissue or Plaque 13 13
Pancreatitis 13 13
Abdominal Distention 12 12
Constipation 12 12
Hair Loss 12 12
Diarrhea 11 11
Fatigue 10 10
Abdominal Cramps 10 10
Internal Organ Perforation 9 9
Fever 9 9
Anemia 9 9
Stomach Ulceration 9 9
Bacterial Infection 8 8
Dyspnea 8 8
Gastritis 8 8
Laceration(s) 7 7
Aspiration/Inhalation 7 7
Cramp(s) 7 7
Unspecified Gastrointestinal Problem 7 7
Implant Pain 6 6
Adhesion(s) 6 6
Ischemia 6 6
Hypersensitivity/Allergic reaction 5 5
Pneumonia 5 5
Necrosis 5 5
Flatus 5 5
Chest Pain 5 5
Aspiration Pneumonitis 5 5
Swelling/ Edema 5 5
Cough 4 4
Cancer 4 4
Bowel Perforation 4 4
Post Operative Wound Infection 4 4
Dizziness 4 4
Cardiac Arrest 4 4
Death 4 4
Nerve Damage 4 4
Irritation 4 4
Hematoma 3 3
Renal Failure 3 3
Swelling 3 3
Urinary Tract Infection 3 3
Eructate 3 3
Airway Obstruction 3 3
Achalasia 3 3
Pulmonary Embolism 3 3
Autoimmune Disorder 3 3
Electrolyte Imbalance 3 3
Weakness 3 3
Complaint, Ill-Defined 3 3
Depression 3 3
Choking 3 3
Laceration(s) of Esophagus 3 3
Sleep Dysfunction 3 3
Syncope/Fainting 3 3
Hematemesis 3 3
Gastrointestinal Hemorrhage 3 3
Unspecified Tissue Injury 3 3
Vitamin Deficiency 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Muscle/Tendon Damage 2 2
Increased Appetite 2 2
Intra-Abdominal Hemorrhage 2 2
Melena 2 2
Wheezing 2 2
Embolism/Embolus 2 2
Lymphoma 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Obalon Therapeutics Inc II Apr-28-2020
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