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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device restraint, protective
Regulation Description Protective restraint.
Product CodeFMQ
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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