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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
2017 54 54
2018 23 23
2019 57 57
2020 38 38
2021 33 33
2022 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 68 68
Adverse Event Without Identified Device or Use Problem 42 42
Mechanical Problem 19 19
Insufficient Information 10 10
Improper or Incorrect Procedure or Method 10 10
Material Split, Cut or Torn 8 8
Device Slipped 8 8
Material Integrity Problem 6 6
Device Operates Differently Than Expected 5 5
Positioning Problem 5 5
Misassembled 4 4
Labelling, Instructions for Use or Training Problem 4 4
Defective Device 4 4
Material Separation 4 4
Detachment of Device or Device Component 3 3
Torn Material 3 3
Mechanics Altered 3 3
Unraveled Material 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Stretched 2 2
Patient Device Interaction Problem 2 2
Defective Component 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Tear, Rip or Hole in Device Packaging 1 1
Detachment Of Device Component 1 1
Difficult to Remove 1 1
Human-Device Interface Problem 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Degraded 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1
Moisture Damage 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 61 61
No Known Impact Or Consequence To Patient 42 42
Extubate 31 31
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 10 10
Skin Tears 6 6
Death 5 5
Emotional Changes 4 4
Bruise/Contusion 4 4
Fall 3 3
Injury 3 3
No Code Available 3 3
No Patient Involvement 2 2
No Information 2 2
Confusion/ Disorientation 2 2
Bone Fracture(s) 2 2
Hemorrhage/Bleeding 1 1
Irritation 1 1
Laceration(s) 1 1
Cardiopulmonary Arrest 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Blood Loss 1 1
Fracture, Arm 1 1
Reinfusion 1 1
Sweating 1 1
Needle Stick/Puncture 1 1
Abrasion 1 1
Not Applicable 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Mar-30-2020
2 Queen Comfort Products lLC II Nov-01-2021
3 TIDI PRODUCTS II Oct-25-2019
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