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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, incontinence, urosheath type, sterile
Product CodeEXJ
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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