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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device garment, protective, for incontinence
Regulation Description Protective garment for incontinence.
Product CodeEYQ
Regulation Number 876.5920
Device Class 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 6
2023 8 8
2024 7 7
2025 5 5
2026 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 21 21
Material Integrity Problem 7 7
Material Disintegration 6 6
Insufficient Device Problem Information 5 5
Product Quality Problem 5 5
Appropriate Device Problem Term/Code Not Available 4 4
Clumping in Device or Device Ingredient 3 3
Gel Leak 2 2
Fluid/Blood Leak 2 2
Failure to Degrade 1 1
Break 1 1
Patient-Device Incompatibility 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Rash 10 11
Skin Inflammation/ Irritation 5 5
Burning Sensation 4 4
Insufficient Information 3 3
Pain 3 3
Hypersensitivity/Allergic reaction 2 2
Discomfort 2 2
Dyspnea 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Unspecified Infection 1 1
Malaise 1 1
Itching Sensation 1 1
Local Reaction 1 1
Chemical Exposure 1 2
Blister 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 2
Eye Irritation 1 1
Erythema 1 2
Hemorrhage/Blood Loss/Bleeding 1 1
Scar Tissue 1 2
Abscess 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Tissue Breakdown 1 1
Urinary Tract Infection 1 1

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