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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
2020 4 4
2021 5 5
2022 5 5
2023 8 8
2024 7 7
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Disintegration 6 6
Insufficient Information 6 6
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Product Quality Problem 2 2
Gel Leak 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 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 8
Insufficient Information 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Skin Inflammation/ Irritation 2 2
Itching Sensation 2 2
Burning Sensation 2 2
Discomfort 2 2
Dyspnea 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Sepsis 1 1
Malaise 1 1
Local Reaction 1 1
Chemical Exposure 1 1
Skin Disorders 1 1
Localized Skin Lesion 1 1
Swelling 1 1
Erythema 1 1
Scar Tissue 1 1
Reaction 1 1
Abscess 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Anaphylactic Shock 1 1
No Consequences Or Impact To Patient 1 1
Urinary Tract Infection 1 1

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