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TPLC
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show TPLC since
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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
2020
38
38
2021
33
33
2022
54
54
2023
47
47
2024
58
58
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
77
77
Device Slipped
35
35
Material Split, Cut or Torn
14
14
Mechanical Problem
11
11
Insufficient Information
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Patient Device Interaction Problem
8
8
Material Frayed
5
5
Defective Component
5
5
Defective Device
5
5
Positioning Problem
5
5
Product Quality Problem
5
5
Human-Device Interface Problem
5
5
Material Disintegration
4
4
Use of Device Problem
4
4
Labelling, Instructions for Use or Training Problem
4
4
Detachment of Device or Device Component
4
4
Activation, Positioning or Separation Problem
3
3
Material Integrity Problem
3
3
Fail-Safe Problem
3
3
Device Handling Problem
3
3
Connection Problem
3
3
Therapeutic or Diagnostic Output Failure
2
2
Difficult or Delayed Separation
2
2
No Apparent Adverse Event
2
2
Appropriate Term/Code Not Available
2
2
Disconnection
1
1
Off-Label Use
1
1
Crack
1
1
Unintended Movement
1
1
Inadequate Instructions for Healthcare Professional
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Protective Measures Problem
1
1
Material Too Soft/Flexible
1
1
Difficult to Open or Close
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
142
142
No Consequences Or Impact To Patient
24
24
Insufficient Information
23
23
Irritability
6
6
Unspecified Mental, Emotional or Behavioural Problem
5
5
No Known Impact Or Consequence To Patient
4
4
Death
3
3
Unintended Extubation
3
3
Emotional Changes
2
2
Bone Fracture(s)
2
2
Confusion/ Disorientation
2
2
Choking
2
2
Extubate
2
2
Loss of consciousness
2
2
Damage to Ligament(s)
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Aspiration/Inhalation
1
1
Head Injury
1
1
Abrasion
1
1
Cardiac Arrest
1
1
Irritation
1
1
Injury
1
1
Foreign Body In Patient
1
1
Concussion
1
1
Numbness
1
1
Fall
1
1
Laceration(s)
1
1
Pain
1
1
Paresis
1
1
Anxiety
1
1
Unspecified Tissue Injury
1
1
Hemorrhage/Bleeding
1
1
Airway Obstruction
1
1
Ventilator Dependent
1
1
Low Oxygen Saturation
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
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