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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, non-absorbable, staple line reinforcement
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Product CodeOXD
Regulation Number 878.3300
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Application Program Shut Down 1 1
Device Sensing Problem 1 1
Increase in Pressure 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Blood Loss/Bleeding 2 2
Hematoma 1 1
Atrial Fibrillation 1 1
Thrombosis/Thrombus 1 1
Tachycardia 1 1

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