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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
2017 1 1
2018 6 6
2019 1 1
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Device Misassembled During Manufacturing /Shipping 2 2
Appropriate Term/Code Not Available 1 1
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 4 4
Pressure Sores 2 2
Hypersensitivity/Allergic reaction 2 2
Patient Problem/Medical Problem 2 2
Osteomyelitis 1 1
Rash 1 1
Burning Sensation 1 1
Numbness 1 1
Post Traumatic Wound Infection 1 1

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