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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device speculum, ent
Product CodeEPY
Regulation Number 878.1800
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 4
Difficult to Open or Close 4 4
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nasal Obstruction 4 4
Patient Problem/Medical Problem 4 4
No Known Impact Or Consequence To Patient 1 1

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