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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device washer of body waste receptacles
Regulation Description Washers for body waste receptacles.
Product CodeFLH
Regulation Number 880.6800
Device Class 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 5 5
2022 6 7
2023 9 9
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 11 11
Use of Device Problem 5 5
Electrical Shorting 3 3
Fluid/Blood Leak 3 4
Defective Component 2 2
Sharp Edges 2 2
Material Frayed 1 1
Leak/Splash 1 1
Break 1 1
Output Problem 1 1
Failure to Auto Stop 1 1
Insufficient Information 1 1
Material Integrity Problem 1 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Patient Involvement 4 4
Sore Throat 4 4
Electric Shock 3 3
Laceration(s) 3 3
Insufficient Information 2 3
Fall 2 2
Blister 1 1
Bruise/Contusion 1 1

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