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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
2016 1 1
2017 2 2
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Material Rupture 2 2
Defective Device 1 1
Detachment of Device or Device Component 1 1
Burst Container or Vessel 1 1
Fluid Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 5 5
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Burn, Thermal 1 1

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