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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
2021 6 6
2022 12 12
2023 13 13
2024 11 11
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Device Tipped Over 10 10
Device Fell 9 9
No Apparent Adverse Event 7 7
Insufficient Information 6 6
Use of Device Problem 6 6
Detachment of Device or Device Component 6 6
Unintended System Motion 6 6
Temperature Problem 4 4
Unintended Movement 3 3
Fracture 3 3
Sharp Edges 2 2
Failure to Disinfect 2 2
Leak/Splash 1 1
Unintended Electrical Shock 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
Insufficient Information 5 5
Burn(s) 4 4
Fall 2 2
Laceration(s) 2 2
Pain 2 2
Decreased Respiratory Rate 2 2
Caustic/Chemical Burns 2 2
Respiratory Arrest 2 2
Eye Pain 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Penner Patient Care, Inc. III Mar-09-2026
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