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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
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2016
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2019
2020
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2023
2024
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Device
implant, intragastric for morbid obesity
Product Code
LTI
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
4
7
10
1
2
3
6
14
14
32
21
5
3
2
4
2
MDR Year
MDR Reports
MDR Events
2014
563
563
2015
556
556
2016
514
514
2017
528
528
2018
453
453
2019
334
334
2020
165
165
2021
193
193
2022
609
609
2023
975
975
2024
102
102
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1153
1153
Adverse Event Without Identified Device or Use Problem
857
857
Insufficient Information
819
819
Deflation Problem
550
550
Device Slipped
395
395
Patient-Device Incompatibility
202
202
Leak/Splash
195
195
Unintended Deflation
185
185
Free or Unrestricted Flow
158
158
Migration or Expulsion of Device
155
155
Inflation Problem
106
106
Material Erosion
87
87
Appropriate Term/Code Not Available
86
86
Migration
71
71
Air/Gas in Device
57
57
Device Operates Differently Than Expected
57
57
Break
51
51
No Apparent Adverse Event
45
45
Detachment of Device or Device Component
37
37
Disconnection
30
30
Use of Device Problem
28
28
Device Issue
24
24
Fracture
18
18
Patient Device Interaction Problem
18
18
Obstruction of Flow
16
16
Detachment Of Device Component
15
15
Malposition of Device
14
14
Device Dislodged or Dislocated
14
14
Improper or Incorrect Procedure or Method
13
13
Material Separation
13
13
Mechanical Problem
13
13
Inadequacy of Device Shape and/or Size
12
12
Unintended Movement
12
12
Extrusion
11
11
Material Integrity Problem
10
10
Difficult to Remove
9
9
Defective Device
8
8
Therapeutic or Diagnostic Output Failure
8
8
Output Problem
7
7
Material Rupture
7
7
Device Inoperable
7
7
Filling Problem
7
7
Entrapment of Device
6
6
Hole In Material
6
6
Kinked
6
6
Nonstandard Device
6
6
Loose or Intermittent Connection
6
6
Material Twisted/Bent
6
6
Material Deformation
6
6
Expulsion
6
6
Infusion or Flow Problem
5
5
Material Perforation
5
5
Defective Component
4
4
Component Missing
4
4
Material Puncture/Hole
4
4
Burst Container or Vessel
4
4
Material Protrusion/Extrusion
4
4
Positioning Problem
4
4
Loosening of Implant Not Related to Bone-Ingrowth
4
4
Human-Device Interface Problem
4
4
Compatibility Problem
3
3
Difficult to Advance
3
3
Connection Problem
3
3
Packaging Problem
3
3
Premature Separation
3
3
Failure to Deflate
3
3
Partial Blockage
3
3
Complete Blockage
3
3
Crack
3
3
Tear, Rip or Hole in Device Packaging
3
3
Device Or Device Fragments Location Unknown
3
3
Short Fill
3
3
Material Too Rigid or Stiff
2
2
Premature Activation
2
2
Increase in Pressure
2
2
Off-Label Use
2
2
Split
2
2
Material Discolored
2
2
Material Disintegration
2
2
Biofilm coating in Device
2
2
Corroded
2
2
Material Fragmentation
2
2
Separation Problem
2
2
Material Split, Cut or Torn
2
2
Pressure Problem
2
2
Torn Material
2
2
Improper Flow or Infusion
2
2
Inadequate Instructions for Non-Healthcare Professional
1
1
Improper Device Output
1
1
Gas/Air Leak
1
1
Activation, Positioning or Separation Problem
1
1
Difficult to Open or Close
1
1
Device Contamination with Chemical or Other Material
1
1
Mechanical Jam
1
1
No Flow
1
1
Firing Problem
1
1
Device Fell
1
1
Misassembly by Users
1
1
Inadequate Instructions for Healthcare Professional
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
1090
1090
Vomiting
996
996
Pain
664
665
Insufficient Information
515
515
Nausea
431
432
Abdominal Pain
410
410
No Clinical Signs, Symptoms or Conditions
360
360
Patient Problem/Medical Problem
347
347
Erosion
311
312
Dysphagia/ Odynophagia
186
187
Regurgitation
186
186
Obstruction/Occlusion
179
180
No Code Available
128
128
Unspecified Infection
126
126
No Known Impact Or Consequence To Patient
118
118
Dehydration
113
113
Pyrosis/Heartburn
111
111
Inflammation
108
108
Hernia
108
108
Weight Changes
96
96
No Information
93
93
Ulcer
72
72
No Consequences Or Impact To Patient
64
64
Malaise
63
64
Perforation
50
50
Internal Organ Perforation
49
49
Hemorrhage/Bleeding
44
44
Adhesion(s)
42
43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
38
38
Fever
37
37
Scar Tissue
37
37
Constipation
35
35
Complaint, Ill-Defined
32
32
Death
32
32
Diarrhea
31
31
Dyspnea
31
31
Discomfort
31
31
Abdominal Cramps
30
30
Abdominal Distention
30
30
Aspiration/Inhalation
30
30
Sepsis
30
30
Irritation
29
29
Chest Pain
27
27
Perforation of Esophagus
27
27
Blood Loss
24
24
Foreign Body In Patient
24
24
Pneumonia
24
24
Other (for use when an appropriate patient code cannot be identified)
24
24
Surgical procedure, additional
23
23
Necrosis
22
22
Gastritis
22
22
Fatigue
20
20
Anemia
17
17
Abscess
17
17
Device Embedded In Tissue or Plaque
17
17
Gastrointestinal Regurgitation
17
17
Cramp(s)
16
16
Hair Loss
14
14
Pancreatitis
14
14
Ischemia
13
13
Swelling
13
13
Dizziness
12
12
Ulceration
11
11
Hypersensitivity/Allergic reaction
11
11
Achalasia
11
11
Pulmonary Embolism
11
11
Bacterial Infection
11
11
Choking
11
11
Depression
10
10
Prolapse
10
10
Autoimmune Disorder
10
10
Cardiac Arrest
10
10
Burning Sensation
10
10
Tachycardia
9
9
Seroma
9
9
Renal Failure
9
9
Syncope
9
9
Flatus
9
9
Stomach Ulceration
9
9
Fluid Discharge
8
8
Injury
8
8
Fistula
8
8
Laceration(s)
8
8
Urinary Tract Infection
8
8
Weakness
8
8
Therapeutic Response, Decreased
8
8
Tissue Damage
7
7
Septic Shock
7
7
Nerve Damage
7
7
Surgical procedure
7
7
Anxiety
7
7
Coma
7
7
Not Applicable
7
7
Sleep Dysfunction
7
7
Unspecified Gastrointestinal Problem
7
7
Implant Pain
6
6
Palpitations
6
6
Bowel Perforation
6
6
Laceration(s) of Esophagus
6
6
Muscle Spasm(s)
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan
II
May-02-2011
2
Allergan
II
Nov-18-2010
3
Apollo Endosurgery Inc
II
Aug-10-2018
4
Apollo Endosurgery Inc
II
Sep-30-2014
5
Ethicon Endo-Surgery Inc
II
Nov-05-2013
6
Ethicon Endo-Surgery Inc
II
Nov-02-2010
7
Obalon Therapeutics Inc
II
Apr-28-2020
8
Reshape Medical Inc
II
Nov-10-2016
9
Reshape Medical Inc
II
Aug-17-2016
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