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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 (for general medical purposes)
Regulation Description Medical support stocking.
Product CodeFQL
Regulation Number 880.5780
Device Class 1

MDR Year MDR Reports MDR Events
2022 3 4
2023 1 1
2024 1 1
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 4 5
Device Slipped 1 1
No Display/Image 1 1
Energy Output Problem 1 1
Patient-Device Incompatibility 1 1
Contamination 1 1
Patient Device Interaction Problem 1 1
Product Quality Problem 1 2
Self-Activation or Keying 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Pain 4 5
Neuropathy 1 1
Sleep Dysfunction 1 1
Hip Fracture 1 1
Vasoconstriction 1 1
Erythema 1 2
Loss of Range of Motion 1 1
Insufficient Information 1 1
Fall 1 1
Swelling/ Edema 1 2
Bruise/Contusion 1 2

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