TPLC - Total Product Life Cycle

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Device	razor, surgical
Regulation Description	Manual surgical instrument for general use.
Product Code	LWK
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Sharp Edges	8	8
Fire	4	4
Break	3	3
Temperature Problem	2	2
Patient Device Interaction Problem	2	2
Inaccurate Information	2	2
Smoking	2	2
Failure to Cut	2	2
Thermal Decomposition of Device	1	1
Output Problem	1	1
Scratched Material	1	1
Insufficient Information	1	1
Explosion	1	1
Use of Device Problem	1	1
Fitting Problem	1	1
Component Missing	1	1
Structural Problem	1	1
Patient-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Device Dislodged or Dislocated	1	1
Labelling, Instructions for Use or Training Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Abrasion	16	16
No Clinical Signs, Symptoms or Conditions	14	14
Laceration(s)	3	3
No Known Impact Or Consequence To Patient	3	3
Erythema	3	3
Skin Inflammation/ Irritation	3	3
Localized Skin Lesion	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Rash	1	1
Loss of Vision	1	1
No Consequences Or Impact To Patient	1	1
No Patient Involvement	1	1
Superficial (First Degree) Burn	1	1
Unspecified Infection	1	1
Insufficient Information	1	1
Reaction	1	1

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