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 Code	QKR
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	75	108
Patient-Device Incompatibility	64	70
Patient Device Interaction Problem	6	8
Product Quality Problem	5	5
Material Integrity Problem	2	2
Material Puncture/Hole	2	5
Device Markings/Labelling Problem	2	2
Break	1	4
Contamination	1	1
Entrapment of Device	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
Defective Device	1	1
Inadequate Instructions for Non-Healthcare Professional	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, 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
Pain	5	6
Skin Disorders	5	5
Asthma	5	28
Loss of consciousness	5	5
Epistaxis	5	6
Syncope/Fainting	4	4
Unspecified Infection	4	5
Sensitivity of Teeth	4	5
Hypersensitivity/Allergic reaction	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Confusion/ Disorientation	4	4
Tachycardia	3	3
Arrhythmia	3	3
Irritability	3	5
Contact Dermatitis	2	2
Swelling/ Edema	2	2
Visual Impairment	2	2
Suicidal Ideation	2	2
Vertigo	2	2
Discomfort	2	2
Loss of Vision	2	2
Vomiting	2	5
Visual Disturbances	2	2
Itching Sensation	2	2
Hemorrhage/Bleeding	2	2
Head Injury	2	2
Presyncope	2	4
Low Oxygen Saturation	2	2
Sleep Dysfunction	2	3
Bacterial Infection	1	1
Respiratory Insufficiency	1	2
Eczema	1	1
Hyperventilation	1	1
Tinnitus	1	1