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TPLC
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show TPLC since
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2023
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Device
restraint, protective
Product Code
FMQ
Regulation Number
880.6760
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
23
23
2019
57
57
2020
38
38
2021
33
33
2022
54
54
2023
42
42
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
81
81
Adverse Event Without Identified Device or Use Problem
29
29
Mechanical Problem
27
27
Device Slipped
17
17
Material Split, Cut or Torn
15
15
Insufficient Information
10
10
Patient Device Interaction Problem
7
7
Defective Device
7
7
Positioning Problem
5
5
Material Integrity Problem
5
5
Defective Component
5
5
Material Frayed
5
5
Labelling, Instructions for Use or Training Problem
4
4
Misassembled
4
4
Product Quality Problem
4
4
Material Disintegration
4
4
Detachment of Device or Device Component
4
4
Fail-Safe Problem
3
3
Human-Device Interface Problem
3
3
Connection Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Material Separation
3
3
Inadequacy of Device Shape and/or Size
2
2
Unraveled Material
2
2
Activation, Positioning or Separation Problem
2
2
Protective Measures Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
No Apparent Adverse Event
2
2
Appropriate Term/Code Not Available
2
2
Material Too Soft/Flexible
1
1
Unintended Movement
1
1
Use of Device Problem
1
1
Crack
1
1
Disconnection
1
1
Structural Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
95
95
No Consequences Or Impact To Patient
60
60
Extubate
21
21
Insufficient Information
18
18
No Known Impact Or Consequence To Patient
12
12
Irritability
5
5
Bruise/Contusion
4
4
Death
4
4
Emotional Changes
3
3
Skin Tears
3
3
No Patient Involvement
2
2
Unintended Extubation
2
2
Fall
2
2
Bone Fracture(s)
2
2
Loss of consciousness
2
2
Injury
2
2
Fracture, Arm
1
1
Ventilator Dependent
1
1
Anxiety
1
1
Complaint, Ill-Defined
1
1
Abrasion
1
1
Reinfusion
1
1
Numbness
1
1
Head Injury
1
1
Hemorrhage/Bleeding
1
1
Irritation
1
1
Laceration(s)
1
1
Pain
1
1
Paresis
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Confusion/ Disorientation
1
1
Blood Loss
1
1
Needle Stick/Puncture
1
1
Not Applicable
1
1
No Information
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Aug-22-2022
2
DeRoyal Industries Inc
II
Mar-30-2020
3
Queen Comfort Products lLC
II
Nov-01-2021
4
TIDI PRODUCTS
II
Oct-25-2019
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