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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shield, nipple
Product CodeHFS
Regulation Number 880.5630
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 2 2
Pain 2 2
Swelling 1 1
Fungal Infection 1 1
Skin Tears 1 1
Unspecified Infection 1 1

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