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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, ear, nose and throat
Product CodeNEA
Regulation Number 872.3275
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2023 9 9
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 8 8
Improper Chemical Reaction 6 6
Chemical Problem 3 3
Leak/Splash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 3 3

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