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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, umbilical
Product CodeHFW
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2018 7 7
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 3 3
Appropriate Term/Code Not Available 2 2
Fail-Safe Did Not Operate 2 2
Break 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 6 6
Muscle Hypotonia 1 1
Cyanosis 1 1
Hemorrhage/Bleeding 1 1
Respiratory Distress Syndrome of Newborns 1 1
No Known Impact Or Consequence To Patient 1 1

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