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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
Material Puncture/Hole 2 2
Defective Device 2 2
Material Integrity Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Break 1 1
Entrapment of Device 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1
Gas/Air Leak 1 1
Device Emits Odor 1 1
Overheating of Device 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
Sore Throat 9 9
Skin Inflammation/ Irritation 9 9
Cough 8 8
Insufficient Information 8 8
Asthma 8 8
Fall 7 7
Emotional Changes 7 7
Depression 7 7
Unspecified Infection 6 6
Hypersensitivity/Allergic reaction 6 6
Tachycardia 6 6
No Known Impact Or Consequence To Patient 6 6
Loss of consciousness 5 5
No Code Available 5 5
Pain 5 5
Itching Sensation 5 5
Skin Disorders 5 5
Syncope/Fainting 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Epistaxis 4 4
Confusion/ Disorientation 4 4
Cognitive Changes 4 4
Low Oxygen Saturation 3 3
Irritability 3 3
Visual Impairment 3 3
Vomiting 3 3
Memory Loss/Impairment 3 3
Skin Irritation 3 3
Arrhythmia 3 3
Sensitivity of Teeth 2 2
Hemorrhage/Bleeding 2 2
Loss of Vision 2 2
Visual Disturbances 2 2
Head Injury 2 2
Bacterial Infection 2 2
Presyncope 2 2
Sweating 2 2
Contact Dermatitis 2 2
Swelling/ Edema 2 2
Reaction 2 2
Ambulation Difficulties 1 1
Lethargy 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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