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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring, teething, fluid-filled
Product CodeKKO
Regulation Number 872.5550
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Opacification 1 1
Crack 1 1
Fail-Safe Problem 1 1
Component Missing 1 1
Device Emits Odor 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Choking 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tomy International Inc. II Dec-22-2022
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