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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hood, surgical
Regulation Description Surgical apparel.
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
THI TOTAL HEALTHCARE INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 6 11
2024 11 13
2025 9 10

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 14 17
Delivered as Unsterile Product 10 16
Device Contamination with Chemical or Other Material 5 5
Material Frayed 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 33
Insufficient Information 2 4

Recalls
Manufacturer Recall Class Date Posted
1 O&M HALYARD, INC. III Apr-02-2024
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