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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
2022 2 2
2023 8 8
2024 13 13
2025 2 2
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 13 13
No Clinical Signs, Symptoms or Conditions 8 8
Asthma 3 3
Eye Irritation 2 2
Neuropathy 1 1
Sleep Dysfunction 1 1
Hypersensitivity/Allergic reaction 1 1
Nasal congestion 1 1
Nausea 1 1
Wheezing 1 1
Epistaxis 1 1
Burning Sensation 1 1
Dyspnea 1 1
Ecchymosis 1 1
Pain 1 1
Choking 1 1
Elevated ketones/Diabetic Ketoacidosis 1 1
Limb 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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