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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device truss, umbilical
Product CodeEXM
Regulation Number 876.5970
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2022 1 1
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Break 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 4 4
Hemorrhage/Bleeding 3 3
Unspecified Infection 3 3
Fluid Discharge 2 2
Not Applicable 2 2
Hypersensitivity/Allergic reaction 1 1
Erythema 1 1
Fever 1 1
Inflammation 1 1
Itching Sensation 1 1
Necrosis 1 1
Pain 1 1
Rash 1 1
Skin Discoloration 1 1
Blood Loss 1 1

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