TPLC - Total Product Life Cycle

• Device: accessory, surgical apparel
• Regulation Description: Surgical apparel.
• Product Code: LYU
• Regulation Number: 878.4040
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	9	9
2021	2	2
2022	4	4
2024	3	3
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Device Unsafe to Use in Environment	3	3
Patient-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Shielding Failure	2	2
Insufficient Information	1	1
Device Fell	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination	1	1
Contamination /Decontamination Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device Dislodged or Dislocated	1	1
Overheating of Device	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7	7
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	3	3
Headache	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Nausea	1	1
Dizziness	1	1
Confusion/ Disorientation	1	1
Rash	1	1
Erythema	1	1
No Patient Involvement	1	1
Dyspnea	1	1
Fall	1	1
Reaction	1	1
Anxiety	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	II	Feb-05-2021
2	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
3	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023