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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
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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