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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device razor, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLWK
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 11 11
2022 8 8
2023 4 4
2024 8 8
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Break 3 3
Fire 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Failure to Cut 2 2
Temperature Problem 2 2
Fitting Problem 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Scratched Material 1 1
Use of Device Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Dislodged or Dislocated 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Abrasion 14 14
Laceration(s) 6 6
Skin Inflammation/ Irritation 3 3
Localized Skin Lesion 2 2
Erythema 2 2
Unspecified Tissue Injury 2 2
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
No Known Impact Or Consequence To Patient 1 1
Rash 1 1
Insufficient Information 1 1
Reaction 1 1
Skin Tears 1 1
Loss of Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-21-2024
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