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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, polishing, abrasive, oral cavity
Product CodeEJR
Regulation Number 872.6030
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 3 3
2021 6 6
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Patient-Device Incompatibility 7 7
Delivered as Unsterile Product 2 2
Material Puncture/Hole 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 10 10
Swelling/ Edema 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Swelling 2 2
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 2 2
Rash 2 2
Anaphylactic Shock 2 2
Burning Sensation 2 2
Sore Throat 2 2
Reaction 1 1
Caustic/Chemical Burns 1 1
Death 1 1
Local Reaction 1 1
Vomiting 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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