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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
Product CodeGDX
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 6 6
2020 8 8
2021 21 21
2022 5 5
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 7 7
Difficult to Open or Remove Packaging Material 7 7
Tear, Rip or Hole in Device Packaging 6 6
Break 4 4
Unintended Movement 4 4
Material Integrity Problem 3 3
Detachment of Device or Device Component 3 3
Pitted 3 3
Degraded 2 2
Unsealed Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Jam 1 1
Device Contamination with Chemical or Other Material 1 1
Material Erosion 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Dull, Blunt 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 4 4
Laceration(s) 3 3
Necrosis 1 1
Hemorrhage/Bleeding 1 1
No Code Available 1 1
Insufficient Information 1 1

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