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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
Product CodeKCO
Regulation Number 874.5220
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1
2018 7 7
2020 2 2
2022 2 2
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 4 4
Product Quality Problem 3 3
Output Problem 3 3
Application Program Problem: Medication Error 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Improper Flow or Infusion 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
No Flow 1 1
Activation Failure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Failure to Deliver 1 1
Device Displays Incorrect Message 1 1
Burst Container or Vessel 1 1
Contamination 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 5 5
Asthma 3 3
Pain 2 2
Respiratory Distress 1 1
No Consequences Or Impact To Patient 1 1
Reaction 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
No Code Available 1 1
Wheezing 1 1
Insufficient Information 1 1
Burn(s) 1 1
Dyspnea 1 1
Ecchymosis 1 1
Fever 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Neuropathy 1 1

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