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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bottle, hot/cold water
Regulation Description Hot/cold water bottle.
Product CodeFPF
Regulation Number 880.6085
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Leak/Splash 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 5 5
Weight Changes 3 3

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