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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, sitz, nonpowered
Product CodeKTC
Regulation Number 890.5125
Device Class 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 76 76
2016 19 19
2019 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 74 74
Device Operates Differently Than Expected 6 6
Fluid/Blood Leak 5 5
Device Emits Odor 3 3
Overheating of Device 3 3
Loose or Intermittent Connection 3 3
Failure To Adhere Or Bond 3 3
Break 2 2
Device Inoperable 2 2
Defective Component 1 1
Device Tipped Over 1 1
Smoking 1 1
Electrical Shorting 1 1
Naturally Worn 1 1
Detachment Of Device Component 1 1
Crack 1 1
Device Maintenance Issue 1 1
Mechanical Problem 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 83 83
No Information 15 15
No Clinical Signs, Symptoms or Conditions 1 1
Contusion 1 1
Fall 1 1
Head Injury 1 1

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