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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua
Definition Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download
Product CodeQKR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 154 198
2022 3 3
2023 1 1
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dyspnea 57 61
Headache 48 53
Dizziness 42 54
Anxiety 24 49
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 18 19
Nausea 14 14
Fatigue 11 15
Rash 9 11
Cough 8 10
Skin Inflammation/ Irritation 8 8
Insufficient Information 8 11
Emotional Changes 7 8
Fall 7 7
Cognitive Changes 7 9
Sore Throat 6 6
Depression 6 6
Skin Disorders 5 5
Asthma 5 28
Loss of consciousness 5 5
Pain 5 6
Epistaxis 5 6
Sensitivity of Teeth 4 5
Unspecified Infection 4 5
No Clinical Signs, Symptoms or Conditions 4 4
Syncope/Fainting 4 4
Confusion/ Disorientation 4 4
Hypersensitivity/Allergic reaction 4 4
Tachycardia 3 3
Irritability 3 5
Arrhythmia 3 3
Visual Disturbances 2 2
Sleep Dysfunction 2 3
Swelling/ Edema 2 2
Suicidal Ideation 2 2
Head Injury 2 2
Contact Dermatitis 2 2
Low Oxygen Saturation 2 2
Presyncope 2 4
Vomiting 2 5
Vertigo 2 2
Loss of Vision 2 2
Visual Impairment 2 2
Discomfort 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Itching Sensation 2 2
Dysphasia 1 1
Speech Disorder 1 1
Malaise 1 1
Ambulation or Postural Difficulties 1 1
Unspecified Eye / Vision Problem 1 1

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