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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device maintainer, space preformed, orthodontic
Product CodeDYT
Regulation Number 872.5525
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 5 5
2019 8 8
2020 2 2
2021 1 1
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 17 17
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7 7
Tooth Fracture 4 4
Swelling 3 3
Chest Pain 3 3
Fatigue 3 3
Pain 3 3
Inflammation 2 2
Burning Sensation 2 2
Asthma 2 2
Sore Throat 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Angioedema 1 1
Vomiting 1 1
Skin Inflammation 1 1
Blood Loss 1 1
Anaphylactic Shock 1 1
Erythema 1 1
Hair Loss 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Dizziness 1 1
Ulcer 1 1
Pressure Sores 1 1
Discomfort 1 1
Irritation 1 1
Nausea 1 1
Rash 1 1
Red Eye(s) 1 1

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