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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mask, scavenging
Product CodeKHA
Regulation Number 868.5590
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Break 1 1
Device Emits Odor 1 1
Device Markings/Labelling Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Swelling/ Edema 1 1
Insufficient Information 1 1
Asthma 1 1
Hypersensitivity/Allergic reaction 1 1
Respiratory Distress 1 1
Burning Sensation 1 1

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