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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device splint, nasal
Product CodeEPP
Regulation Number 874.5800
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 3 3
Hematoma 2 2
Necrosis 2 2
Post Operative Wound Infection 2 2
Respiratory Insufficiency 1 1
Swelling/ Edema 1 1
Fungal Infection 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1
Dyspnea 1 1
Headache 1 1

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