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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, transdermal delivery, cder or cber led
Definition Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect.
Product CodeQIX
Device Class Not Classified

MDR Year MDR Reports MDR Events
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Manufacturing, Packaging or Shipping Problem 3 3
Defective Device 2 2
Insufficient Device Problem Information 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Loss of consciousness 2 2
Extreme Exhaustion 1 1
Dizziness 1 1
Itching Sensation 1 1
Blister 1 1
Medical device site infection 1 1
Burn(s) 1 1
Rash 1 1
Erythema 1 1
Pain 1 1
Scar Tissue 1 1
Myocardial Infarction 1 1
Decreased Respiratory Rate 1 1
Full thickness (Third Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

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