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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pick, massaging
Product CodeJET
Regulation Number 872.6650
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2021 2 2
2022 39 39
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 20 20
No Clinical Signs, Symptoms or Conditions 16 16
Device Embedded In Tissue or Plaque 7 7
Foreign Body In Patient 2 2
Skin Inflammation/ Irritation 1 1
Abscess 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Swelling 1 1
Sore Throat 1 1
Tooth Fracture 1 1
Choking 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Water Pik, Inc. II Aug-08-2018
2 Young Dental Manufacturing I, LLC III Dec-19-2022
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