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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Misassembled During Manufacturing /Shipping 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Labelling, Instructions for Use or Training Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ulcer 3 3
Hypersensitivity/Allergic reaction 2 2
Rash 1 1
Burning Sensation 1 1
Osteomyelitis 1 1

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