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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator, ent
Regulation Description Ear, nose, and throat drug administration device.
Product CodeKCJ
Regulation Number 874.5220
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 3 3
2023 4 4
2024 5 5
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Product Quality Problem 2 2
Device Emits Odor 2 2
Difficult to Open or Remove Packaging Material 1 1
Patient-Device Incompatibility 1 1
Patient Device Interaction Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
Dizziness 4 4
Headache 3 3
Cough 3 3
Pain 3 3
Burning Sensation 3 3
Diarrhea 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Itching Sensation 2 2
Fall 1 1
Fatigue 1 1
Head Injury 1 1
Hematoma 1 1
Unspecified Infection 1 1
Unspecified Tissue Injury 1 1
Alteration in Body Temperature 1 1
Swelling/ Edema 1 1
Discomfort 1 1
Impaired Healing 1 1
Loss of consciousness 1 1
Abdominal Cramps 1 1
Fluid Discharge 1 1
Convulsion/Seizure 1 1
Epistaxis 1 1
Nausea 1 1
Perforation 1 1
Vomiting 1 1
Chills 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Neilmed Pharmaceuticals Inc II Feb-05-2025
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