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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
2014
11
11
2015
11
11
2016
6
6
2017
8
8
2018
20
20
2019
28
28
2020
4
4
2021
5
5
2022
5
5
2023
8
8
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
39
39
Patient-Device Incompatibility
21
21
Insufficient Information
12
12
Material Disintegration
4
4
Break
3
3
Device Emits Odor
3
3
Product Quality Problem
3
3
Device Operates Differently Than Expected
3
3
Material Split, Cut or Torn
3
3
Torn Material
2
2
Appropriate Term/Code Not Available
2
2
Defective Component
2
2
Gel Leak
2
2
Material Separation
2
2
Failure To Service
1
1
Inadequacy of Device Shape and/or Size
1
1
Unraveled Material
1
1
Improper or Incorrect Procedure or Method
1
1
Leak/Splash
1
1
Clumping in Device or Device Ingredient
1
1
Component Falling
1
1
Microbial Contamination of Device
1
1
Device Appears to Trigger Rejection
1
1
Device Dislodged or Dislocated
1
1
Device Contamination with Chemical or Other Material
1
1
Incorrect Device Or Component Shipped
1
1
Contamination of Device Ingredient or Reagent
1
1
Physical Property Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Urinary Tract Infection
22
22
Pain
21
21
Rash
21
21
Itching Sensation
14
14
Skin Irritation
12
12
Unspecified Infection
11
11
Burning Sensation
10
10
Fever
9
9
Irritation
8
8
Sepsis
8
8
Discomfort
8
8
No Consequences Or Impact To Patient
5
5
Swelling
4
4
Injury
4
4
Abnormal Vaginal Discharge
4
4
Reaction
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Inflammation
4
4
Abscess
4
4
Bacterial Infection
3
3
Dyspnea
3
3
Erythema
3
3
Fall
3
3
Headache
3
3
Insufficient Information
3
3
Fungal Infection
3
3
Caustic/Chemical Burns
3
3
Scar Tissue
2
2
Blood Loss
2
2
No Known Impact Or Consequence To Patient
2
2
Partial thickness (Second Degree) Burn
2
2
Hypersensitivity/Allergic reaction
2
2
Nausea
2
2
Respiratory Distress
2
2
Local Reaction
2
2
Bone Fracture(s)
2
2
Fungus
2
2
Gangrene
2
2
Purulent Discharge
2
2
Anaphylactic Shock
2
2
Antibiotics, Reaction To
1
1
Asthma
1
1
Abrasion
1
1
Cyst(s)
1
1
Diarrhea
1
1
Foreign Body Reaction
1
1
Fatigue
1
1
Renal Failure
1
1
Staphylococcus Aureus
1
1
Incontinence
1
1
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Miscarriage
1
1
No Code Available
1
1
Pregnancy
1
1
Skin Disorders
1
1
Skin Inflammation/ Irritation
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematuria
1
1
Chemical Exposure
1
1
Respiratory Failure
1
1
Numbness
1
1
Vomiting
1
1
Malaise
1
1
Joint Dislocation
1
1
Swollen Lymph Nodes
1
1
Skin Discoloration
1
1
Heart Failure
1
1
Urinary Frequency
1
1
Urticaria
1
1
Pressure Sores
1
1
Anxiety
1
1
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