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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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New Search show TPLC since Back to Search Results
Device hood, surgical
Regulation Description Surgical apparel.
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 6 6
2018 1 1
2019 4 5
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 5 5
Material Integrity Problem 4 5
Adverse Event Without Identified Device or Use Problem 2 2
Biofilm coating in Device 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 10
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Skin Irritation 1 1

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