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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device razor, surgical
Product CodeLWK
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 31 31
2020 9 9
2021 11 11
2022 8 8
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Fire 9 9
Overheating of Device 7 7
Smoking 6 6
Sharp Edges 4 4
Break 3 3
Thermal Decomposition of Device 2 2
Component Missing 2 2
Inaccurate Information 2 2
Failure to Cut 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Structural Problem 1 1
Off-Label Use 1 1
Output Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Labelling, Instructions for Use or Training Problem 1 1
Melted 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 18 18
No Known Impact Or Consequence To Patient 12 12
No Patient Involvement 9 9
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 8 8
Skin Tears 3 3
Skin Inflammation/ Irritation 3 3
Erythema 3 3
Laceration(s) 2 2
Rash 2 2
Unspecified Tissue Injury 2 2
Insufficient Information 1 1
Reaction 1 1
Skin Inflammation 1 1
Skin Discoloration 1 1
Loss of Vision 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-21-2024
2 3M Company - Health Care Business II Jan-30-2019
3 Medline Industries Inc II Sep-26-2019
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