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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, fluidotherapy
Product CodeLSB
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2015 3 3
2018 1 1
2019 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 2 2
Temperature Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Device Operational Issue 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 2 2
No Patient Involvement 2 2
Anaphylactic Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1

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