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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, collagen, large abdominal wall defects
Definition For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Product CodeOXK
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2022 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 2 2
Hemorrhage/Bleeding 2 2

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