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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
Product CodeEYQ
Regulation Number 876.5920
Device Class 1

MDR Year MDR Reports MDR Events
2019 28 28
2020 4 4
2021 5 5
2022 5 5
2023 8 8
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22 22
Patient-Device Incompatibility 7 7
Material Disintegration 6 6
Insufficient Information 5 5
Appropriate Term/Code Not Available 3 3
Device Emits Odor 2 2
Product Quality Problem 2 2
Gel Leak 2 2
Leak/Splash 1 1
Material Split, Cut or Torn 1 1
Microbial Contamination of Device 1 1
Unraveled Material 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 10 10
Pain 10 10
Rash 10 10
Skin Irritation 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Itching Sensation 8 8
Sepsis 6 6
Burning Sensation 6 6
Irritation 6 6
Abnormal Vaginal Discharge 4 4
Discomfort 4 4
Fever 4 4
Dyspnea 3 3
Insufficient Information 3 3
Swelling 3 3
Partial thickness (Second Degree) Burn 2 2
Caustic/Chemical Burns 2 2
Anaphylactic Shock 2 2
Erythema 2 2
Blood Loss 2 2
Skin Inflammation/ Irritation 2 2
Fungal Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Skin Disorders 1 1
Skin Discoloration 1 1
Chemical Exposure 1 1
Local Reaction 1 1
Abrasion 1 1
Asthma 1 1
Purulent Discharge 1 1
Malaise 1 1
Diarrhea 1 1
Cyst(s) 1 1
Inflammation 1 1
Scar Tissue 1 1
Reaction 1 1
Gangrene 1 1
Anxiety 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Headache 1 1
Bacterial Infection 1 1
No Consequences Or Impact To Patient 1 1

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