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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blade, scalpel
Product CodeGES
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 53 53
2020 35 35
2021 35 35
2022 21 21
2023 28 28
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 87 87
Dull, Blunt 18 18
Fracture 12 12
Insufficient Information 11 11
Material Integrity Problem 10 10
Manufacturing, Packaging or Shipping Problem 6 6
Failure to Cut 6 6
Tear, Rip or Hole in Device Packaging 6 6
Packaging Problem 5 5
Unsealed Device Packaging 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Difficult to Remove 3 3
Product Quality Problem 3 3
Detachment of Device or Device Component 3 3
Difficult to Open or Close 3 3
Entrapment of Device 2 2
Difficult to Open or Remove Packaging Material 2 2
Degraded 2 2
Device Handling Problem 2 2
Delivered as Unsterile Product 2 2
Mechanical Problem 1 1
Device Contamination with Body Fluid 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Material Discolored 1 1
Material Too Rigid or Stiff 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Defective Device 1 1
Defective Component 1 1
Structural Problem 1 1
No Apparent Adverse Event 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Material Too Soft/Flexible 1 1
Nonstandard Device 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Foreign Body In Patient 32 32
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 16 16
No Consequences Or Impact To Patient 15 15
Laceration(s) 6 6
Injury 5 5
Device Embedded In Tissue or Plaque 4 4
No Information 3 3
No Patient Involvement 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Nervous System Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Southmedic, Inc. II Nov-23-2022
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