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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, hydro-massage
Regulation Description Immersion hydrobath.
Product CodeILJ
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2020 14 14
2021 6 6
2022 12 12
2023 13 13
2024 11 11
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Device Tipped Over 14 14
Device Fell 14 14
Detachment of Device or Device Component 8 8
No Apparent Adverse Event 7 7
Unintended System Motion 7 7
Insufficient Information 6 6
Use of Device Problem 6 6
Unintended Movement 5 5
Fracture 5 5
Temperature Problem 4 4
Leak/Splash 2 2
Sharp Edges 2 2
Failure to Disinfect 2 2
Unstable 1 1
Unintended Electrical Shock 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Consequences Or Impact To Patient 8 8
Insufficient Information 5 5
Burn(s) 4 4
Fall 3 3
Respiratory Arrest 2 2
Bone Fracture(s) 2 2
No Patient Involvement 2 2
Pain 2 2
Laceration(s) 2 2
Caustic/Chemical Burns 2 2
Decreased Respiratory Rate 2 2
Bruise/Contusion 2 2
Electric Shock 1 1
Chemical Exposure 1 1
Rash 1 1
Eye Pain 1 1

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