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TPLC
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Device
restraint, protective
Regulation Description
Protective restraint.
Product Code
FMQ
Regulation Number
880.6760
Device Class
1
MDR Year
MDR Reports
MDR Events
2021
33
33
2022
54
54
2023
47
47
2024
58
58
2025
15
15
2026
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
48
48
Device Slipped
35
35
Mechanical Problem
11
11
Insufficient Device Problem Information
9
9
Material Frayed
5
5
Labelling, Instructions for Use or Training Problem
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Material Split, Cut or Torn
5
5
Use of Device Problem
4
4
Difficult to Open or Close
4
4
Human-Device Interface Problem
4
4
Positioning Problem
4
4
Patient Device Interaction Problem
4
4
Device Handling Problem
3
3
Material Disintegration
2
2
Material Puncture/Hole
2
2
Product Quality Problem
2
2
Appropriate Device Problem Term/Code Not Available
2
2
Difficult or Delayed Separation
2
2
Disconnection
1
1
Loose or Intermittent Connection
1
1
Off-Label Use
1
1
Material Separation
1
1
Defective Component
1
1
Defective Device
1
1
Activation, Positioning or Separation Problem
1
1
Material Integrity Problem
1
1
Unintended Movement
1
1
Material Too Soft/Flexible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
154
154
Insufficient Information
22
22
Irritability
6
6
Unspecified Mental, Emotional or Behavioural Problem
5
5
Unintended Extubation
5
5
Loss of consciousness
2
2
Abrasion
2
2
Choking
2
2
Bone Fracture(s)
2
2
Emotional Changes
2
2
No Consequences Or Impact To Patient
2
2
Cardiac Arrest
1
1
Aspiration/Inhalation
1
1
Damage to Ligament(s)
1
1
Laceration(s)
1
1
Numbness
1
1
Death
1
1
Low Oxygen Saturation
1
1
Airway Obstruction
1
1
Head Injury
1
1
Paresis
1
1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
1
1
Anxiety
1
1
Pain
1
1
Confusion/ Disorientation
1
1
Fall
1
1
Concussion
1
1
Needle Stick/Puncture
1
1
Extubate
1
1
Ventilator Dependent
1
1
Foreign Body In Patient
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Aug-22-2022
2
Queen Comfort Products lLC
II
Nov-01-2021
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