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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue adhesive for internal use
Regulation Description Tissue adhesive.
Definition Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
Product CodePJK
Regulation Number 878.4010
Device Class 3

MDR Year MDR Reports MDR Events
2024 1 1
2025 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Infection 2 2
Impaired Healing 1 1
Wound Dehiscence 1 1
Insufficient Information 1 1

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