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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device restraint, protective
Product CodeFMQ
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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