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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette
Product CodeHTF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 5 5
2021 16 16
2022 8 8
2023 8 8
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 22 22
Material Integrity Problem 7 7
Fracture 5 5
Crack 2 2
Contamination /Decontamination Problem 2 2
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Unsealed Device Packaging 1 1
Material Separation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 5 5
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 2 2
Death 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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