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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
Product CodeILJ
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2019 22 22
2020 14 14
2021 6 6
2022 12 12
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 21 21
Device Tipped Over 12 12
Fracture 7 7
Unintended Movement 7 7
Unintended System Motion 6 6
Detachment of Device or Device Component 6 6
Insufficient Information 4 4
Temperature Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Use of Device Problem 3 3
Failure to Disinfect 2 2
Unintended Electrical Shock 2 2
Sharp Edges 2 2
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1
Installation-Related Problem 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Unstable 1 1
Leak/Splash 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Consequences Or Impact To Patient 16 16
No Patient Involvement 8 8
Pain 5 5
Fall 5 5
Burn(s) 4 4
Insufficient Information 3 3
Death 2 2
Bruise/Contusion 2 2
Bone Fracture(s) 2 2
Laceration(s) 2 2
Injury 2 2
Decreased Respiratory Rate 2 2
Skin Tears 2 2
Caustic/Chemical Burns 2 2
Electric Shock 2 2
Chemical Exposure 1 1
Chest Tightness/Pressure 1 1
Shock 1 1
Myocardial Infarction 1 1
Abrasion 1 1
Chest Pain 1 1
Contusion 1 1
Eye Pain 1 1

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