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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device basin, emesis
Product CodeFNY
Regulation Number 880.6730
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3 3
Device Contamination with Chemical or Other Material 1 1
Sticking 1 1
Device Contamination With Biological Material 1 1
Hole In Material 1 1
Device Packaging Compromised 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination 1 1
Material Discolored 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 3 3
Blood Loss 2 2
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Jul-03-2023
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