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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bell, circumcision
Product CodeFHG
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 3 3
Folded 1 1
Device Operates Differently Than Expected 1 1
Sharp Edges 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 1 1
Urinary Retention 1 1
Injury 1 1
Skin Tears 1 1
Blood Loss 1 1

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