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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device face mask per enforcement policy for face masks and respirators during the covid-19 public health emergency
Definition Face mask is intended to be worn by general public or healthcare personnel and excludes N95 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 subject to the Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance.
Product CodeQKR
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 63 63
2021 139 139

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 110 110
Patient-Device Incompatibility 70 70
Patient Device Interaction Problem 6 6
Product Quality Problem 3 3
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 1 1
Unintended Movement 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Entrapment of Device 1 1
Gas Leak 1 1
Insufficient Information 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dyspnea 77 77
Headache 61 61
Dizziness 56 56
Anxiety 31 31
Nausea 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Fatigue 12 12
Sore Throat 9 9
Skin Inflammation/ Irritation 9 9
Asthma 8 8
Rash 8 8
Cough 8 8
Emotional Changes 7 7
Fall 7 7
Depression 7 7
Tachycardia 6 6
No Known Impact Or Consequence To Patient 6 6
Loss of consciousness 5 5
Hypersensitivity/Allergic reaction 5 5
Pain 5 5
Unspecified Infection 5 5
No Code Available 5 5
Skin Disorders 5 5
Syncope/Fainting 4 4
Confusion/ Disorientation 4 4
Cognitive Changes 4 4
Epistaxis 4 4
Low Oxygen Saturation 3 3
Skin Irritation 3 3
Memory Loss/Impairment 3 3
Insufficient Information 3 3
Irritability 3 3
Itching Sensation 3 3
Visual Impairment 3 3
Arrhythmia 3 3
Hemorrhage/Bleeding 2 2
Bacterial Infection 2 2
Loss of Vision 2 2
Vomiting 2 2
Head Injury 2 2
Reaction 2 2
Presyncope 2 2
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Sensitivity of Teeth 2 2
Sweating 2 2
Contact Dermatitis 2 2
Visual Disturbances 2 2
Ulcer 1 1
Malaise 1 1
Joint Dislocation 1 1
Numbness 1 1
Irritation 1 1
Skin Discoloration 1 1
Herpes 1 1
Anemia 1 1
Conjunctivitis 1 1
Cyst(s) 1 1
Dysphagia/ Odynophagia 1 1
Eczema 1 1
Suicidal Ideation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Respiratory Problem 1 1
Unspecified Eye / Vision Problem 1 1
Vertigo 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Lethargy 1 1
Fluid Discharge 1 1
Alteration in Body Temperature 1 1
Skin Infection 1 1
Respiratory Insufficiency 1 1
Eye Pain 1 1
Multiple Fractures 1 1
Chest Tightness/Pressure 1 1
Choking 1 1
Chemical Exposure 1 1
Tinnitus 1 1
Dysphasia 1 1
Therapeutic Response, Decreased 1 1
Distress 1 1
Discomfort 1 1
Arthralgia 1 1
Weakness 1 1
Scar Tissue 1 1
Exposure to Body Fluids 1 1
Bone Fracture(s) 1 1
Hyperventilation 1 1
Abnormal Blood Gases 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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