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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device hood, surgical
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THI TOTAL HEALTHCARE INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 5
2020 1 1
2021 1 1
2022 2 2
2023 6 11
2024 11 14

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 10 16
Device Contaminated During Manufacture or Shipping 6 9
Device Contamination with Chemical or Other Material 5 5
Material Integrity Problem 3 4
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Biofilm coating in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 24
No Consequences Or Impact To Patient 3 4
Insufficient Information 2 4
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1

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