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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
2018 21 21
2019 22 22
2020 14 14
2021 6 6
2022 12 12
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 23 23
Device Tipped Over 11 11
Unintended System Motion 8 8
Fracture 7 7
Detachment of Device or Device Component 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Unintended Movement 5 5
Insufficient Information 5 5
Temperature Problem 4 4
Installation-Related Problem 3 3
Unintended Electrical Shock 3 3
Mechanical Problem 3 3
Use of Device Problem 3 3
Misassembled 2 2
Failure to Align 2 2
Component Falling 2 2
Failure to Disinfect 2 2
Sharp Edges 2 2
Break 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Difficult to Open or Close 1 1
No Apparent Adverse Event 1 1
Leak/Splash 1 1
Material Separation 1 1
Device Inoperable 1 1
Unstable 1 1
Arcing 1 1
Patient-Device Incompatibility 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 25 25
No Patient Involvement 19 19
No Clinical Signs, Symptoms or Conditions 15 15
Pain 6 6
Fall 6 6
Burn(s) 4 4
Bruise/Contusion 3 3
Insufficient Information 3 3
Electric Shock 3 3
Laceration(s) 3 3
Decreased Respiratory Rate 2 2
Skin Tears 2 2
Caustic/Chemical Burns 2 2
Partial thickness (Second Degree) Burn 2 2
Bone Fracture(s) 2 2
Contusion 2 2
Death 2 2
Erythema 2 2
Injury 2 2
Skin Inflammation 1 1
Chest Tightness/Pressure 1 1
Shock 1 1
Skin Irritation 1 1
Swelling 1 1
Burning Sensation 1 1
Head Injury 1 1
Abrasion 1 1
Chest Pain 1 1
Eye Pain 1 1
Burn, Thermal 1 1
Myocardial Infarction 1 1
Chemical Exposure 1 1
Superficial (First Degree) Burn 1 1

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