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TPLC
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show TPLC since
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Device
accessory, surgical apparel
Product Code
LYU
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
Device Operates Differently Than Expected
2
2
Patient-Device Incompatibility
2
2
Contamination /Decontamination Problem
2
2
Material Integrity Problem
2
2
Appropriate Term/Code Not Available
2
2
Insufficient Information
1
1
Detachment of Device or Device Component
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Packaging Compromised
1
1
Device Dislodged or Dislocated
1
1
Electromagnetic Compatibility Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Deformation
1
1
Material Puncture/Hole
1
1
Device Displays Incorrect Message
1
1
Hole In Material
1
1
Loose or Intermittent Connection
1
1
Device Inoperable
1
1
Defective Component
1
1
Out-Of-Box Failure
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
No Information
2
2
Irritation
2
2
Rash
1
1
Anxiety
1
1
Reaction
1
1
Burn(s)
1
1
Erythema
1
1
Fall
1
1
Headache
1
1
Hypersensitivity/Allergic reaction
1
1
No Code Available
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
4
Zimmer Biomet, Inc.
II
Feb-01-2018
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