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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nebulizer, medicinal, non-ventilatory (atomizer)
Product CodeCCQ
Regulation Number 868.5640
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 2 2
2023 7 7
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Unsealed Device Packaging 2 2
Complete Blockage 2 2
Obstruction of Flow 2 2
Material Separation 2 2
Suction Failure 1 1
Defective Device 1 1
Failure to Deliver 1 1
Failure to Advance 1 1
Human-Device Interface Problem 1 1
Self-Activation or Keying 1 1
Leak/Splash 1 1
Disconnection 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1

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