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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device inhaler, metered dose or dry powder, cder or cber led
Definition Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Product CodeQKS
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 5 5
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 5 5
Manufacturing, Packaging or Shipping Problem 2 2
Mechanics Altered 1 1
Component Misassembled 1 1
Complete Blockage 1 1
Excess Flow or Over-Infusion 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 1 1
Respiratory Insufficiency 1 1

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