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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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Disintegration 6 6
Insufficient Information 6 6
Appropriate Term/Code Not Available 4 4
Gel Leak 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient-Device Incompatibility 2 3
Product Quality Problem 2 2
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Leak/Splash 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Rash 8 9
Skin Inflammation/ Irritation 3 3
Burning Sensation 3 3
Insufficient Information 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Dyspnea 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Malaise 1 1
Chemical Exposure 1 2
Skin Disorders 1 2
Itching Sensation 1 1
Localized Skin Lesion 1 1
Local Reaction 1 1
Discomfort 1 1
Erythema 1 2
Scar Tissue 1 2
Abscess 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Anaphylactic Shock 1 1
Urinary Tract Infection 1 1

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