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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, nasal
Product CodeLWF
Regulation Number 874.3900
Device Class 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 4 4
2022 5 5
2023 2 2
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Insufficient Information 6 6
Failure to Obtain Sample 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 5 5
Cancer 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abrasion 2 2
Cellulitis 2 2
Rash 2 2
Skin Tears 2 2
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
Skin Irritation 1 1
No Code Available 1 1
Skull Fracture 1 1
Dry Eye(s) 1 1
Anaphylactoid 1 1
Blister 1 1
Localized Skin Lesion 1 1
Skin Discoloration 1 1
Skin Erosion 1 1
Burning Sensation 1 1
Diarrhea 1 1
Erythema 1 1
Peeling 1 1
Visual Impairment 1 1
Contact Dermatitis 1 1
Swelling/ Edema 1 1
Headache 1 1
Wheal(s) 1 1
Deformity/ Disfigurement 1 1
Bruise/Contusion 1 1
Skin Burning Sensation 1 1

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