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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
Regulation Description Immersion hydrobath.
Product CodeILM
Regulation Number 890.5100
Device Class 2

MDR Year MDR Reports MDR Events
2016 20 20
2017 6 6
2018 2 2
2019 6 6
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Tipped Over 8 8
No Apparent Adverse Event 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Detachment Of Device Component 3 3
Component Falling 3 3
Installation-Related Problem 3 3
Temperature Problem 3 3
Use of Device Problem 2 2
Leak/Splash 2 2
Chemical Spillage 2 2
Failure To Adhere Or Bond 1 1
Unintended Movement 1 1
Device Fell 1 1
Unintended System Motion 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Disconnection 1 1
Failure to Disinfect 1 1
Filling Problem 1 1
Hole In Material 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Human Factors Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
Urinary Tract Infection 5 5
No Patient Involvement 5 5
Bruise/Contusion 4 4
No Known Impact Or Consequence To Patient 4 4
Fall 3 3
Partial thickness (Second Degree) Burn 2 2
Headache 2 2
Injury 2 2
Chemical Exposure 2 2
Tissue Damage 2 2
Alteration In Body Temperature 1 1
Tingling 1 1
Pain 1 1
Death 1 1
Skin Irritation 1 1
Concussion 1 1
Sweating 1 1
Palpitations 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Superficial (First Degree) Burn 1 1
Burn(s) 1 1

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