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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, isolation, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Product CodeFRT
Regulation Number 878.5070
Device Class 2

MDR Year MDR Reports MDR Events
2024 12 12
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Device Appears to Trigger Rejection 6 6
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 11 11
Seroma 2 2
Capsular Contracture 2 2
Rupture 1 1

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