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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brush, dermabrasion, powered
Product CodeGFE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 7 7
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Patient-Device Incompatibility 2 2
Unintended Electrical Shock 1 1
Sparking 1 1
Difficult to Remove 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Material Frayed 1 1
Fail-Safe Problem 1 1
Leak/Splash 1 1
Material Too Rigid or Stiff 1 1
Patient Device Interaction Problem 1 1
Thermal Decomposition of Device 1 1
Break 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Rash 3 3
Insufficient Information 2 2
Cataract 1 1
Pain 1 1
Scarring 1 1
Visual Impairment 1 1
Burn, Thermal 1 1
Electric Shock 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Inflammation/ Irritation 1 1

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