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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nasal spray, ent delivery
Regulation Description Ear, nose, and throat drug administration device.
Product CodeKCO
Regulation Number 874.5220
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 5
2022 2 2
2023 8 8
2024 13 13
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 4 4
Output Problem 3 3
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Activation, Positioning or Separation Problem 1 1
Unsealed Device Packaging 1 1
Therapeutic or Diagnostic Output Failure 1 4
Air/Gas in Device 1 1
Activation Failure 1 1
Inaccurate Delivery 1 1
Device Displays Incorrect Message 1 1
Mechanical Jam 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 11 11
No Clinical Signs, Symptoms or Conditions 9 12
Asthma 3 3
Neuropathy 1 1
Sleep Dysfunction 1 1
Hypersensitivity/Allergic reaction 1 1
Wheezing 1 1
Nausea 1 1
Diabetic Ketoacidosis 1 1
No Known Impact Or Consequence To Patient 1 1
Epistaxis 1 1
Burning Sensation 1 1
Dyspnea 1 1
Ecchymosis 1 1
Pain 1 1
Headache 1 1
Hyperemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
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