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TPLC
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show TPLC since
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2024
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Device
stent, metallic, expandable, duodenal
Product Code
MUM
Regulation Number
878.3610
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
TAEWOONG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
43
43
2015
51
51
2016
41
41
2017
85
85
2018
49
49
2019
35
35
2020
32
32
2021
70
70
2022
28
28
2023
52
52
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
99
99
Fracture
82
82
Activation, Positioning or Separation Problem
81
81
Adverse Event Without Identified Device or Use Problem
72
72
Activation Failure
43
43
Migration
42
42
Positioning Problem
37
37
Migration or Expulsion of Device
37
37
Premature Activation
26
26
Material Deformation
24
24
Delivery System Failure
22
22
Partial Blockage
19
19
Positioning Failure
16
16
Difficult to Remove
15
15
Insufficient Information
15
15
Improper or Incorrect Procedure or Method
11
11
Appropriate Term/Code Not Available
10
10
Difficult or Delayed Positioning
7
7
Detachment of Device or Device Component
7
7
Off-Label Use
6
6
Device Stenosis
5
5
Kinked
5
5
Use of Device Problem
5
5
Complete Blockage
4
4
Difficult to Advance
4
4
Device Damaged Prior to Use
3
3
Defective Device
3
3
Obstruction of Flow
3
3
Occlusion Within Device
3
3
Material Twisted/Bent
3
3
Activation Problem
2
2
Entrapment of Device
2
2
Collapse
2
2
Unsealed Device Packaging
2
2
Structural Problem
2
2
Material Separation
2
2
Failure to Advance
2
2
Deformation Due to Compressive Stress
2
2
Physical Resistance/Sticking
1
1
Delivery System Issue, No Description
1
1
Unclear Information
1
1
Material Frayed
1
1
Material Integrity Problem
1
1
Device Packaging Compromised
1
1
Material Perforation
1
1
Packaging Problem
1
1
Retraction Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Fragmentation
1
1
Unraveled Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
141
141
No Clinical Signs, Symptoms or Conditions
88
88
No Known Impact Or Consequence To Patient
79
79
Perforation
51
51
Obstruction/Occlusion
46
46
Vomiting
28
28
Hemorrhage/Bleeding
20
20
Death
20
20
Stenosis
14
14
Abdominal Pain
13
13
Erosion
13
13
Inflammation
12
12
No Code Available
11
11
Occlusion
11
11
Insufficient Information
10
10
Pneumonia
8
8
Gastrointestinal Hemorrhage
7
7
Aspiration/Inhalation
7
7
Foreign Body In Patient
7
7
No Information
6
6
Unspecified Infection
5
5
Nausea
4
4
Pain
4
4
Peritonitis
4
4
Bowel Perforation
3
3
Fever
3
3
Constipation
2
2
Feeding Problem
2
2
Reocclusion
2
2
Laceration(s)
2
2
Discomfort
2
2
Thrombosis/Thrombus
2
2
Migration
2
2
Cardiac Arrest
2
2
Anemia
2
2
Abdominal Distention
2
2
Hematoma
2
2
Necrosis
2
2
Pancreatitis
2
2
Blood Loss
1
1
No Patient Involvement
1
1
Foreign body, removal of
1
1
Surgical procedure, additional
1
1
Sepsis
1
1
Abscess
1
1
Dysphagia/ Odynophagia
1
1
Failure of Implant
1
1
Shock
1
1
Ulcer
1
1
Hypoxia
1
1
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