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TPLC
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show TPLC since
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2024
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Device
garment, protective, for incontinence
Product Code
EYQ
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
2
2
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
Insufficient Information
5
5
Appropriate Term/Code Not Available
3
3
Material Disintegration
3
3
Device Emits Odor
2
2
Product Quality Problem
2
2
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Unraveled Material
1
1
Microbial Contamination of Device
1
1
Material Split, Cut or Torn
1
1
Gel Leak
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
10
10
Rash
10
10
Urinary Tract Infection
10
10
Skin Irritation
9
9
Itching Sensation
8
8
Sepsis
6
6
Burning Sensation
6
6
Irritation
6
6
Fever
4
4
Abnormal Vaginal Discharge
4
4
Discomfort
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Insufficient Information
3
3
Swelling
3
3
Dyspnea
3
3
Erythema
2
2
Anaphylactic Shock
2
2
Hypersensitivity/Allergic reaction
2
2
Unspecified Infection
2
2
Fungal Infection
2
2
Caustic/Chemical Burns
2
2
Blood Loss
2
2
Partial thickness (Second Degree) Burn
2
2
Skin Disorders
1
1
Skin Inflammation/ Irritation
1
1
Swelling/ Edema
1
1
Chemical Exposure
1
1
Malaise
1
1
Reaction
1
1
Skin Discoloration
1
1
No Consequences Or Impact To Patient
1
1
Anxiety
1
1
Inflammation
1
1
Abrasion
1
1
Local Reaction
1
1
Scar Tissue
1
1
Asthma
1
1
Bacterial Infection
1
1
Cyst(s)
1
1
Diarrhea
1
1
Purulent Discharge
1
1
Gangrene
1
1
Headache
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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