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TPLC
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show TPLC since
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Device
device, incontinence, urosheath type, sterile
Product Code
EXJ
Regulation Number
876.5250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
6
6
2016
6
6
2017
1
1
2020
1
1
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4
4
Device Operates Differently Than Expected
3
3
Difficult to Remove
2
2
Insufficient Information
2
2
Patient Device Interaction Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Component Missing
1
1
Patient-Device Incompatibility
1
1
Device Contamination with Chemical or Other Material
1
1
Failure To Adhere Or Bond
1
1
Hole In Material
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
4
4
Erythema
3
3
Peeling
2
2
Skin Irritation
2
2
Swelling
2
2
Tissue Damage
2
2
No Known Impact Or Consequence To Patient
2
2
No Code Available
1
1
Urinary Tract Infection
1
1
Burning Sensation
1
1
Reaction
1
1
Skin Tears
1
1
Tissue Breakdown
1
1
Dysuria
1
1
Skin Discoloration
1
1
Abrasion
1
1
Erosion
1
1
Fungus
1
1
Unspecified Infection
1
1
Inflammation
1
1
Itching Sensation
1
1
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