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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scalpel, one-piece
Regulation Description Manual surgical instrument for general use.
Product CodeGDX
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 1 1
2019 6 6
2020 8 8
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 6 6
Difficult to Open or Remove Packaging Material 6 6
Mechanical Problem 5 5
Unintended Movement 4 4
Material Integrity Problem 3 3
Pitted 3 3
Break 3 3
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Device Packaging Compromised 1 1
Dull, Blunt 1 1
Contamination /Decontamination Problem 1 1
Material Erosion 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 4 4
Laceration(s) 3 3
Foreign Body In Patient 2 2
No Code Available 1 1
Necrosis 1 1
Injury 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Southmedic, Inc. II May-17-2018
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