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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessory, surgical apparel
Product CodeLYU
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 1 1
2022 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 2 2
Device Unsafe to Use in Environment 2 2
Detachment of Device or Device Component 2 2
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 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 4 4
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
No Patient Involvement 1 1
Erythema 1 1
Fall 1 1
Reaction 1 1
Anxiety 1 1
Headache 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
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