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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 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 74 74
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
Patient Device Interaction Problem 7 7
Defective Device 7 7
Positioning Problem 5 5
Material Integrity Problem 5 5
Material Frayed 5 5
Defective Component 5 5
Product Quality Problem 5 5
Material Disintegration 4 4
Labelling, Instructions for Use or Training Problem 4 4
Misassembled 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
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
Difficult or Delayed Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 2 2
Structural Problem 1 1
Material Separation 1 1
Off-Label Use 1 1
Crack 1 1
Disconnection 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Material Too Soft/Flexible 1 1
Device Handling Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 126
No Consequences Or Impact To Patient 51 51
Extubate 21 21
Insufficient Information 19 19
No Known Impact Or Consequence To Patient 6 6
Irritability 5 5
Death 3 3
Emotional Changes 3 3
Skin Tears 3 3
Loss of consciousness 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Injury 2 2
Unintended Extubation 2 2
No Patient Involvement 2 2
Choking 2 2
Bone Fracture(s) 2 2
Confusion/ Disorientation 2 2
No Code Available 1 1
Not Applicable 1 1
Unspecified Tissue Injury 1 1
Paresis 1 1
Abrasion 1 1
Anxiety 1 1
Ventilator Dependent 1 1
Laceration(s) 1 1
Concussion 1 1
Pain 1 1
Needle Stick/Puncture 1 1
Head Injury 1 1
Numbness 1 1
Fall 1 1
Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Reinfusion 1 1
Hemorrhage/Bleeding 1 1
Damage to Ligament(s) 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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