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TPLC
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show TPLC since
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Device
dilator, esophageal
Product Code
KNQ
Regulation Number
876.5365
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
388
388
2020
364
364
2021
351
351
2022
274
274
2023
319
319
2024
128
128
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
486
486
Material Rupture
429
429
Material Puncture/Hole
261
261
Fluid/Blood Leak
146
146
Fracture
122
122
Deflation Problem
94
94
Adverse Event Without Identified Device or Use Problem
60
60
Leak/Splash
57
57
Use of Device Problem
48
48
Detachment of Device or Device Component
47
47
Break
47
47
Failure to Deflate
46
46
Inflation Problem
42
42
Difficult to Remove
39
39
Material Twisted/Bent
38
38
Crack
25
25
Off-Label Use
22
22
Material Fragmentation
15
15
Material Integrity Problem
15
15
Material Deformation
14
14
Improper or Incorrect Procedure or Method
13
13
Appropriate Term/Code Not Available
8
8
Physical Resistance/Sticking
7
7
Device-Device Incompatibility
6
6
Difficult to Advance
6
6
Retraction Problem
6
6
Deformation Due to Compressive Stress
6
6
Failure to Advance
5
5
Material Split, Cut or Torn
4
4
Entrapment of Device
4
4
Difficult to Insert
3
3
Packaging Problem
3
3
Mechanical Problem
3
3
Defective Device
3
3
Device Contamination with Chemical or Other Material
3
3
Material Separation
3
3
Shipping Damage or Problem
3
3
Failure to Eject
3
3
Tear, Rip or Hole in Device Packaging
3
3
Gas/Air Leak
3
3
Contamination
2
2
No Pressure
2
2
Accessory Incompatible
2
2
Device Misassembled During Manufacturing /Shipping
1
1
Device Contaminated During Manufacture or Shipping
1
1
Unintended Movement
1
1
Incomplete or Missing Packaging
1
1
Complete Blockage
1
1
Mechanical Jam
1
1
Device Damaged by Another Device
1
1
Unsealed Device Packaging
1
1
Material Perforation
1
1
Insufficient Information
1
1
Output Problem
1
1
Device Damaged Prior to Use
1
1
Device Fell
1
1
Migration
1
1
Migration or Expulsion of Device
1
1
Infusion or Flow Problem
1
1
Human-Device Interface Problem
1
1
Degraded
1
1
Unintended Deflation
1
1
Device Dislodged or Dislocated
1
1
Obstruction of Flow
1
1
Connection Problem
1
1
Unraveled Material
1
1
Contamination /Decontamination Problem
1
1
Delivered as Unsterile Product
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1002
1002
No Consequences Or Impact To Patient
646
646
No Known Impact Or Consequence To Patient
69
69
Insufficient Information
22
22
No Patient Involvement
20
20
Foreign Body In Patient
18
18
Perforation of Esophagus
13
13
Perforation
12
12
Laceration(s) of Esophagus
9
9
Device Embedded In Tissue or Plaque
9
9
Hemorrhage/Bleeding
8
8
Gastrointestinal Hemorrhage
6
6
Chest Pain
4
4
Death
3
3
Aspiration/Inhalation
3
3
Laceration(s)
3
3
Unspecified Tissue Injury
3
3
Low Oxygen Saturation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Code Available
2
2
Cough
2
2
Obstruction/Occlusion
1
1
Needle Stick/Puncture
1
1
Patient Problem/Medical Problem
1
1
Pancreatitis
1
1
Unspecified Gastrointestinal Problem
1
1
Nerve Damage
1
1
Pain
1
1
Tissue Damage
1
1
Vomiting
1
1
Anxiety
1
1
Injury
1
1
Fever
1
1
Fistula
1
1
Hemostasis
1
1
Inflammation
1
1
Abdominal Pain
1
1
Abscess
1
1
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