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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mirror, mouth
Product CodeEAX
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 4 4
2017 1 1
2018 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Material Integrity Problem 3 3
Insufficient Information 1 1
Device Fell 1 1
Defective Device 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Intermittent Continuity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 2 2
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sunstar Americas, Inc. II Apr-09-2021
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