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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, skin closure
Regulation Description Removable skin clip.
Product CodeMKY
Regulation Number 878.4320
Device Class 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 3 3
Necrosis 2 2
Blister 2 2
Impaired Healing 1 1
Needle Stick/Puncture 1 1
Nerve Damage 1 1
Unspecified Tissue Injury 1 1

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