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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device evacuator, vapor, cement monomer
Product CodeJDY
Regulation Number 888.4220
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 1 1
2019 2 2
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 3 3
Device Contaminated During Manufacture or Shipping 3 3
Break 2 2
Loss of or Failure to Bond 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 1 1
No Patient Involvement 1 1
Pain 1 1

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