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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
2019 9 9
2020 3 3
2023 9 9
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 8 8
Improper Chemical Reaction 6 6
Chemical Problem 4 4
Difficult or Delayed Activation 3 3
Clumping in Device or Device Ingredient 3 3
Fluid/Blood Leak 1 1
Leak/Splash 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 4 4
No Patient Involvement 3 3

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