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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device decontamination systems for n95 respirators
Definition Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Product CodeQKY
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 48 48
Break 13 13
Device Emits Odor 13 13
Fluid/Blood Leak 13 13
Insufficient Information 4 4
Material Frayed 3 3
Leak/Splash 3 3
Stretched 3 3
Material Opacification 1 1
Unintended Electrical Shock 1 1
Material Deformation 1 1
Environmental Particulates 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Viral Infection 33 33
No Clinical Signs, Symptoms or Conditions 31 31
Nasal Obstruction 18 18
Sore Throat 16 16
Cough 14 14
Skin Inflammation/ Irritation 12 12
Burning Sensation 11 11
Headache 10 10
Fatigue 9 9
Dyspnea 8 8
Discomfort 7 7
Nausea 6 6
Fever 5 5
Chills 5 5
Diarrhea 5 5
Hypersensitivity/Allergic reaction 4 4
Skin Discoloration 4 4
Rash 4 4
Itching Sensation 3 3
Burn(s) 3 3
Ageusia 2 2
Electric Shock 1 1
Dizziness 1 1
Chemical Exposure 1 1
Blister 1 1
Cellulitis 1 1
Epistaxis 1 1
Neck Pain 1 1
Caustic/Chemical Burns 1 1
Eye Pain 1 1
Skin Burning Sensation 1 1

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