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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
Product CodeLPP
Regulation Number 868.2500
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 3 3
Burn, Thermal 2 2
Partial thickness (Second Degree) Burn 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer America Inc II Aug-08-2013
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