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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stocking, medical support (to prevent pooling of blood in legs)
Product CodeDWL
Regulation Number 880.5780
Device Class 2

MDR Year MDR Reports MDR Events
2018 2 2
2019 1 1
2020 3 3
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Product Quality Problem 2 2
Therapy Delivered to Incorrect Body Area 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Paralysis 1 1
Rash 1 1
Discomfort 1 1
Injury 1 1
Skin Tears 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
Muscle/Tendon Damage 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Bruise/Contusion 1 1
Edema 1 1

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