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TPLC
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Device
pouch, colostomy
Regulation Description
Ostomy pouch and accessories.
Product Code
EZQ
Regulation Number
876.5900
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
381
381
2021
118
118
2022
94
94
2023
90
90
2024
53
53
Device Problems
MDRs with this Device Problem
Events in those MDRs
Malposition of Device
484
484
Sharp Edges
126
126
Material Too Rigid or Stiff
69
69
Positioning Problem
59
59
Fluid/Blood Leak
30
30
Adverse Event Without Identified Device or Use Problem
22
22
Appropriate Term/Code Not Available
20
20
Material Protrusion/Extrusion
4
4
Obstruction of Flow
4
4
Material Too Soft/Flexible
4
4
Material Disintegration
3
3
Insufficient Information
3
3
Improper or Incorrect Procedure or Method
2
2
Material Erosion
1
1
Gas/Air Leak
1
1
Noise, Audible
1
1
Product Quality Problem
1
1
Device Handling Problem
1
1
Leak/Splash
1
1
Off-Label Use
1
1
Material Deformation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
315
315
No Clinical Signs, Symptoms or Conditions
173
173
Skin Inflammation/ Irritation
58
58
Abrasion
45
45
No Patient Involvement
44
44
Hemorrhage/Bleeding
35
35
Pain
34
34
Distress
32
32
Tissue Damage
24
24
Blood Loss
22
22
Pressure Sores
10
10
Blister
9
9
Tissue Breakdown
8
8
Itching Sensation
8
8
Urinary Tract Infection
7
7
Erythema
7
7
Rash
6
6
Laceration(s)
5
5
Hypersensitivity/Allergic reaction
4
4
Discomfort
4
4
Ulcer
2
2
Urticaria
2
2
Skin Irritation
2
2
Reaction
2
2
Fungal Infection
2
2
Granuloma
2
2
Necrosis
1
1
Contact Dermatitis
1
1
Embolism/Embolus
1
1
Purulent Discharge
1
1
Cellulitis
1
1
Emotional Changes
1
1
Inflammation
1
1
Drug Resistant Bacterial Infection
1
1
Skin Infection
1
1
Skin Discoloration
1
1
Bacterial Infection
1
1
Burning Sensation
1
1
Nodule
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
Oct-24-2022
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