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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, sitz, powered
Product CodeILM
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Device Tipped Over 2 2
Detachment of Device or Device Component 1 1
Disconnection 1 1
Unintended System Motion 1 1
Temperature Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
Urinary Tract Infection 5 5
Skin Tears 1 1
Superficial (First Degree) Burn 1 1
Bruise/Contusion 1 1
Fall 1 1
Pain 1 1
Tissue Damage 1 1

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