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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
2019 57 57
2020 38 38
2021 33 33
2022 54 54
2023 47 47
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 81 81
Device Slipped 38 38
Mechanical Problem 28 28
Adverse Event Without Identified Device or Use Problem 26 26
Material Split, Cut or Torn 15 15
Insufficient Information 10 10
Defective Device 7 7
Patient Device Interaction Problem 7 7
Material Frayed 5 5
Defective Component 5 5
Material Integrity Problem 5 5
Positioning Problem 5 5
Product Quality Problem 5 5
Material Disintegration 4 4
Misassembled 4 4
Labelling, Instructions for Use or Training Problem 4 4
Detachment of Device or Device Component 4 4
Fail-Safe Problem 3 3
Connection Problem 3 3
Human-Device Interface Problem 3 3
Activation, Positioning or Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Use of Device Problem 2 2
Difficult or Delayed Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
No Apparent Adverse Event 2 2
Protective Measures Problem 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
Structural Problem 1 1
Device Handling Problem 1 1
Material Separation 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 131 131
No Consequences Or Impact To Patient 51 51
Insufficient Information 21 21
Extubate 21 21
No Known Impact Or Consequence To Patient 6 6
Irritability 5 5
Death 3 3
Emotional Changes 3 3
Skin Tears 3 3
Bone Fracture(s) 2 2
Confusion/ Disorientation 2 2
Injury 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
No Patient Involvement 2 2
Choking 2 2
Loss of consciousness 2 2
Unintended Extubation 2 2
Damage to Ligament(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
No Code Available 1 1
Head Injury 1 1
Abrasion 1 1
Cardiac Arrest 1 1
Irritation 1 1
Needle Stick/Puncture 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
Reinfusion 1 1
Ventilator Dependent 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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