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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 4

MDR Year MDR Reports MDR Events
2019 334 334
2020 165 165
2021 193 193
2022 609 609
2023 975 975
2024 325 325

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 735 735
Deflation Problem 641 641
Fluid/Blood Leak 357 357
Adverse Event Without Identified Device or Use Problem 212 212
Patient-Device Incompatibility 194 194
Unintended Deflation 185 185
Device Slipped 159 159
Inflation Problem 109 109
Air/Gas in Device 91 91
Migration 77 77
Migration or Expulsion of Device 75 75
Leak/Splash 69 69
Use of Device Problem 55 55
Material Erosion 48 48
Patient Device Interaction Problem 22 22
Material Separation 22 22
Detachment of Device or Device Component 21 21
Break 14 14
Appropriate Term/Code Not Available 13 13
Mechanical Problem 10 10
Disconnection 9 9
Difficult to Remove 9 9
Unintended Movement 9 9
Obstruction of Flow 8 8
Fracture 8 8
Output Problem 7 7
Infusion or Flow Problem 6 6
No Apparent Adverse Event 6 6
Improper or Incorrect Procedure or Method 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Integrity Problem 5 5
Burst Container or Vessel 5 5
Material Twisted/Bent 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Difficult to Advance 4 4
Premature Separation 3 3
Failure to Deflate 3 3
Partial Blockage 3 3
Inadequacy of Device Shape and/or Size 3 3
Nonstandard Device 3 3
Complete Blockage 3 3
Compatibility Problem 3 3
Expulsion 3 3
Material Split, Cut or Torn 2 2
Material Protrusion/Extrusion 2 2
Material Rupture 2 2
Material Too Rigid or Stiff 2 2
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 557 557
No Clinical Signs, Symptoms or Conditions 469 469
Vomiting 463 463
Failure of Implant 408 408
Abdominal Pain 253 253
Pain 202 202
Nausea 152 152
Erosion 137 137
Pyrosis/Heartburn 70 70
Obstruction/Occlusion 64 64
Dysphagia/ Odynophagia 61 61
No Information 55 55
Hernia 43 43
Dehydration 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
No Code Available 33 33
No Known Impact Or Consequence To Patient 28 28
Perforation 26 26
Weight Changes 24 24
No Consequences Or Impact To Patient 24 24
Unspecified Infection 22 22
Ulcer 22 22
Patient Problem/Medical Problem 20 20
Scar Tissue 20 20
Discomfort 19 19
Hemorrhage/Bleeding 17 17
Inflammation 17 17
Perforation of Esophagus 17 17
Gastrointestinal Regurgitation 17 17
Regurgitation 17 17
Sepsis 16 16
Malaise 15 15
Foreign Body In Patient 15 15
Pancreatitis 14 14
Device Embedded In Tissue or Plaque 13 13
Hair Loss 12 12
Abdominal Distention 12 12
Constipation 12 12
Diarrhea 11 11
Stomach Ulceration 11 11
Fatigue 10 10
Abdominal Cramps 10 10
Laceration(s) 9 9
Anemia 9 9
Gastritis 9 9
Internal Organ Perforation 9 9
Fever 9 9
Dyspnea 8 8
Bacterial Infection 8 8
Unspecified Gastrointestinal Problem 7 7

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