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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
2014 7 7
2015 1 1
2016 49 49
2017 11 11
2018 1 1
2019 1 1
2020 9 9
2021 1 1
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Torn Material 25 25
Split 14 14
Break 12 12
Overheating of Device 7 7
Crack 4 4
Material Too Rigid or Stiff 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Component Falling 3 3
Contamination /Decontamination Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Patient-Device Incompatibility 2 2
Defective Component 1 1
Device Inoperable 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Puncture/Hole 1 1
Electromagnetic Compatibility Problem 1 1
Device Displays Incorrect Message 1 1
Loose or Intermittent Connection 1 1
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Out-Of-Box Failure 1 1
Hole In Material 1 1
Device Packaging Compromised 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48 48
No Patient Involvement 13 13
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Irritation 2 2
No Information 2 2
Hypersensitivity/Allergic reaction 1 1
Fall 1 1
Rash 1 1
Erythema 1 1
Headache 1 1
Anxiety 1 1
Reaction 1 1
Skin Burning Sensation 1 1
Burn(s) 1 1
No Code Available 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
4 Zimmer Biomet, Inc. II Feb-01-2018
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