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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gouge, surgical, general & plastic surgery
Product CodeGDH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 13 13
2018 3 3
2019 4 4
2020 2 2
2021 5 5
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Detachment Of Device Component 8 8
Difficult to Insert 2 2
Device Packaging Compromised 2 2
Packaging Problem 2 2
Pitted 1 1
Detachment of Device or Device Component 1 1
Corroded 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 6 6
No Patient Involvement 2 2
Foreign Body In Patient 1 1

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