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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
2020 63 63
2021 149 149
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 112 112
Patient-Device Incompatibility 74 74
Product Quality Problem 7 7
Patient Device Interaction Problem 6 6
Device Markings/Labelling Problem 4 4
Device Contamination with Chemical or Other Material 2 2
Defective Device 2 2
Material Integrity Problem 2 2
Material Puncture/Hole 2 2
Gas/Air Leak 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Use of Device Problem 1 1
Device Emits Odor 1 1
Entrapment of Device 1 1
Unintended Movement 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Overheating of Device 1 1
Break 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dyspnea 78 78
Headache 62 62
Dizziness 57 57
Anxiety 31 31
Nausea 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Fatigue 13 13
Rash 11 11
Skin Inflammation/ Irritation 9 9
Sore Throat 9 9
Insufficient Information 8 8
Asthma 8 8
Cough 8 8
Fall 7 7
Depression 7 7
Emotional Changes 7 7
Hypersensitivity/Allergic reaction 6 6
Tachycardia 6 6
No Known Impact Or Consequence To Patient 6 6
Unspecified Infection 6 6
No Code Available 5 5
Pain 5 5
Loss of consciousness 5 5
Itching Sensation 5 5
Skin Disorders 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Epistaxis 4 4
Cognitive Changes 4 4
Confusion/ Disorientation 4 4
Syncope/Fainting 4 4
Vomiting 3 3
Low Oxygen Saturation 3 3
Memory Loss/Impairment 3 3
Irritability 3 3
Skin Irritation 3 3
Visual Impairment 3 3
Arrhythmia 3 3
Reaction 2 2
Sensitivity of Teeth 2 2
Contact Dermatitis 2 2
Loss of Vision 2 2
Head Injury 2 2
Presyncope 2 2
Visual Disturbances 2 2
Bacterial Infection 2 2
Sweating 2 2
Hemorrhage/Bleeding 2 2
Swelling/ Edema 2 2
Chest Tightness/Pressure 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA II Oct-14-2020
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