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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorber, saliva, paper
Product CodeKHR
Regulation Number 872.6050
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Local Reaction 1 1
Swelling 1 1
Reaction 1 1

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