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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device polymer, ent synthetic, porous polyethylene
Regulation Description Ear, nose, and throat synthetic polymer material.
Product CodeJOF
Regulation Number 874.3620
Device Class 2

MDR Year MDR Reports MDR Events
2023 20 24

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 19 23
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling/ Edema 20 24
Erythema 1 1

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