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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device band, elastic, orthodontic
Product CodeECI
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2017 1 1
2018 1 1
2020 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 7 7
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 7 7
Physical Asymmetry 3 3
Reaction 2 2
Skin Inflammation/ Irritation 1 1
Foreign Body Reaction 1 1
Itching Sensation 1 1
Swelling 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Oct-05-2011
2 G & H Wire Company II Feb-02-2024
3 G & H Wire Company II Mar-03-2021
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