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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
2016 24 24
2017 54 54
2018 23 23
2019 57 57
2020 38 38
2021 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
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
Device Operates Differently Than Expected 9 9
Device Slipped 8 8
Material Integrity Problem 8 8
Torn Material 7 7
Material Split, Cut or Torn 6 6
Positioning Problem 5 5
Defective Component 5 5
Misassembled 4 4
Material Separation 4 4
Labelling, Instructions for Use or Training Problem 4 4
Defective Device 4 4
Detachment of Device or Device Component 3 3
Stretched 3 3
Mechanics Altered 3 3
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Unraveled Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Degraded 1 1
Difficult to Remove 1 1
Difficult to Open or Close 1 1
Escape 1 1
Human-Device Interface Problem 1 1
Protective Measures Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Moisture Damage 1 1
Detachment Of Device Component 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 73 73
No Known Impact Or Consequence To Patient 45 45
Extubate 32 32
No Clinical Signs, Symptoms or Conditions 19 19
Insufficient Information 8 8
Fall 8 8
Skin Tears 6 6
Death 5 5
Bruise/Contusion 4 4
Skin Erosion 4 4
Emotional Changes 3 3
No Code Available 3 3
Injury 3 3
Confusion/ Disorientation 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
No Information 2 2
No Patient Involvement 2 2
Not Applicable 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Hemorrhage/Bleeding 1 1
Blood Loss 1 1
Reinfusion 1 1
Needle Stick/Puncture 1 1
Cardiopulmonary Arrest 1 1
Hematoma 1 1
Irritation 1 1
Sweating 1 1
Fracture, Arm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Mar-30-2020
2 TIDI PRODUCTS II Oct-25-2019
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