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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 17 17
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 53 53
Detachment of Device or Device Component 10 10
Material Separation 5 5
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Insufficient Information 20 20
Device Embedded In Tissue or Plaque 9 9
Foreign Body In Patient 2 2
Laceration(s) 2 2
Hypersensitivity/Allergic reaction 1 1
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Tooth Fracture 1 1
Swelling 1 1
Choking 1 1
Abscess 1 1
Sore Throat 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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