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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


Premarket Reviews
ManufacturerDecision
CPAPNEA MEDICAL SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
VENTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 41 41
2016 39 39
2017 13 13
2018 15 15
2019 13 13
2020 6 6
2021 4 4
2022 5 5
2023 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 83 83
Insufficient Information 20 20
Patient-Device Incompatibility 14 14
Failure to Obtain Sample 11 11
Device Operates Differently Than Expected 11 11
Product Quality Problem 7 7
Appropriate Term/Code Not Available 4 4
Unexpected Therapeutic Results 3 3
Material Integrity Problem 2 2
Failure To Adhere Or Bond 2 2
Improper or Incorrect Procedure or Method 2 2
Detachment Of Device Component 1 1
Invalid Sensing 1 1
Unintended Movement 1 1
Use of Device Problem 1 1
Missing Value Reason 1 1
Inadequate Storage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 53 53
Skin Irritation 15 15
Cancer 13 13
Hypersensitivity/Allergic reaction 12 12
Swelling 11 11
Burning Sensation 11 11
Erythema 10 10
Bruise/Contusion 10 10
Reaction 8 8
Pain 8 8
Unspecified Infection 6 6
Skin Tears 6 6
Rash 6 6
Hemorrhage/Bleeding 6 6
Scar Tissue 5 5
Irritation 5 5
Convulsion/Seizure 5 5
No Code Available 5 5
Deformity/ Disfigurement 4 4
Itching Sensation 4 4
Seizures 4 4
Dyspnea 4 4
Tissue Damage 4 4
Skin Inflammation/ Irritation 3 3
Local Reaction 3 3
Skin Discoloration 3 3
Complaint, Ill-Defined 3 3
Peeling 3 3
Sleep Dysfunction 3 3
Anaphylactic Shock 3 3
Therapeutic Effects, Unexpected 2 2
Purulent Discharge 2 2
Headache 2 2
Chest Tightness/Pressure 2 2
Cellulitis 2 2
Nausea 2 2
Emotional Changes 2 2
Ulcer 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 2 2
Choking 2 2
Anxiety 2 2
Wheal(s) 1 1
Tissue Breakdown 1 1
Erosion 1 1
Bacterial Infection 1 1
Partial thickness (Second Degree) Burn 1 1
Increased Sensitivity 1 1
Skin Burning Sensation 1 1

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