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TPLC
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show TPLC since
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Device
device, fixation, tracheal tube
Product Code
CBH
Regulation Number
868.5770
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
30
30
2020
67
67
2021
27
27
2022
47
47
2023
22
22
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
38
38
Adverse Event Without Identified Device or Use Problem
35
35
Material Separation
23
23
Device Dislodged or Dislocated
12
12
Fracture
10
10
Loss of or Failure to Bond
9
9
Detachment of Device or Device Component
7
7
Insufficient Information
7
7
Separation Problem
5
5
Material Split, Cut or Torn
4
4
Device Slipped
4
4
No Apparent Adverse Event
4
4
Use of Device Problem
4
4
Appropriate Term/Code Not Available
3
3
Difficult to Open or Close
3
3
Component Missing
3
3
Improper or Incorrect Procedure or Method
2
2
Loose or Intermittent Connection
2
2
Material Deformation
2
2
Sharp Edges
2
2
Material Integrity Problem
2
2
Positioning Problem
2
2
Gas/Air Leak
2
2
Patient Device Interaction Problem
2
2
Disconnection
2
2
Material Frayed
2
2
Material Twisted/Bent
1
1
Material Too Rigid or Stiff
1
1
Stretched
1
1
Premature Separation
1
1
Material Fragmentation
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Disintegration
1
1
Device Fell
1
1
Entrapment of Device
1
1
Malposition of Device
1
1
Inflation Problem
1
1
Physical Resistance/Sticking
1
1
Migration
1
1
Mechanical Problem
1
1
Incomplete or Missing Packaging
1
1
Connection Problem
1
1
Nonstandard Device
1
1
Inadequate or Insufficient Training
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
38
38
No Consequences Or Impact To Patient
35
35
Insufficient Information
24
24
No Known Impact Or Consequence To Patient
19
19
Extubate
16
16
Tissue Breakdown
13
13
Pressure Sores
13
13
Hypoventilation
12
12
Unspecified Tissue Injury
5
5
Skin Tears
5
5
Cardiac Arrest
4
4
Skin Erosion
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Unintended Extubation
3
3
Not Applicable
2
2
Airway Obstruction
2
2
Skin Discoloration
2
2
Foreign Body In Patient
2
2
Injury
2
2
Laceration(s)
2
2
Ulcer
2
2
Unspecified Respiratory Problem
2
2
Hypoxia
2
2
Aspiration Pneumonitis
1
1
Device Embedded In Tissue or Plaque
1
1
Respiratory Failure
1
1
Low Oxygen Saturation
1
1
Respiratory Insufficiency
1
1
Bradycardia
1
1
Fluid Discharge
1
1
Choking
1
1
Fall
1
1
Pleural Effusion
1
1
Rash
1
1
Atrial Fibrillation
1
1
Inflammation
1
1
Skin Inflammation/ Irritation
1
1
Respiratory Distress
1
1
Respiratory Arrest
1
1
No Code Available
1
1
Unspecified Infection
1
1
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