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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insoles, medical
Regulation Description Medical insole.
Product CodeKYS
Regulation Number 880.6280
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 2 2
2024 4 4
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ulcer 6 6
Tissue Breakdown 4 4
Hypersensitivity/Allergic reaction 1 1
Sepsis 1 1
Osteomyelitis 1 1
Laceration(s) 1 1

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