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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
Regulation Description Surgical apparel.
Product CodeLYU
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2016 49 49
2017 11 11
2018 1 1
2019 1 1
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Torn Material 25 25
Split 14 14
Break 12 12
Crack 4 4
Material Too Rigid or Stiff 4 4
Component Falling 3 3
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Overheating of Device 2 2
Device Operates Differently Than Expected 2 2
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Material Puncture/Hole 1 1
Hole In Material 1 1
Out-Of-Box Failure 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Device Inoperable 1 1
Defective Component 1 1
Device Displays Incorrect Message 1 1
Contamination /Decontamination Problem 1 1
Electromagnetic Compatibility Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 47 47
No Patient Involvement 8 8
No Consequences Or Impact To Patient 6 6
No Information 2 2
No Code Available 1 1
Headache 1 1
Anxiety 1 1
Reaction 1 1
Burn(s) 1 1
Erythema 1 1
Fall 1 1
Skin Burning Sensation 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Feb-05-2021
2 Zimmer Biomet, Inc. II Feb-01-2018
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