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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
2021 1 1
2022 1 1
2023 1 1
2024 1 1
2026 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 69 69
Defective Device 4 4
Manufacturing, Packaging or Shipping Problem 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Display or Visual Feedback Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
Unspecified Respiratory Problem 1 1
Respiratory Insufficiency 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

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