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TPLC
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show TPLC since
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Device
pouch, colostomy
Product Code
EZQ
Regulation Number
876.5900
Device Class
1
Premarket Reviews
Manufacturer
Decision
CONVATEC
SUBSTANTIALLY EQUIVALENT
1
CONVATEC INC
SUBSTANTIALLY EQUIVALENT
1
CONVATEC INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
248
248
2015
160
160
2016
66
66
2017
7
7
2018
342
342
2019
246
246
2020
381
381
2021
118
118
2022
94
94
2023
90
90
2024
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
Malposition of Device
1054
1054
Adverse Event Without Identified Device or Use Problem
293
293
Sharp Edges
117
117
Material Too Rigid or Stiff
79
79
Positioning Problem
78
78
Difficult to Remove
64
64
Human-Device Interface Problem
55
55
Fluid/Blood Leak
43
43
Appropriate Term/Code Not Available
22
22
Leak/Splash
13
13
Product Quality Problem
13
13
Device Operates Differently Than Expected
12
12
Insufficient Information
11
11
Defective Device
11
11
Sticking
10
10
Material Disintegration
6
6
Failure To Adhere Or Bond
5
5
Device Handling Problem
5
5
Device Markings/Labelling Problem
5
5
Material Too Soft/Flexible
4
4
Obstruction of Flow
4
4
Material Protrusion/Extrusion
4
4
Increased Sensitivity
4
4
Loss of or Failure to Bond
3
3
Incomplete or Missing Packaging
3
3
Material Deformation
3
3
Nonstandard Device
2
2
Activation Failure
2
2
Device Contamination with Chemical or Other Material
2
2
Inflation Problem
2
2
Packaging Problem
2
2
Material Integrity Problem
2
2
Off-Label Use
2
2
Use of Device Problem
2
2
Delamination
2
2
Scratched Material
2
2
Defective Component
1
1
Material Puncture/Hole
1
1
Patient-Device Incompatibility
1
1
Material Erosion
1
1
Crack
1
1
Burst Container or Vessel
1
1
Break
1
1
Misassembled
1
1
Material Rupture
1
1
Temperature Problem
1
1
Detachment of Device or Device Component
1
1
Dull, Blunt
1
1
Noise, Audible
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
747
747
No Clinical Signs, Symptoms or Conditions
173
173
No Patient Involvement
147
147
Skin Irritation
145
145
Rash
116
116
Tissue Damage
112
112
Itching Sensation
98
98
No Known Impact Or Consequence To Patient
76
76
Skin Discoloration
72
72
Pain
51
51
Skin Inflammation/ Irritation
48
48
Erythema
47
47
Abrasion
42
42
Hemorrhage/Bleeding
39
39
Blood Loss
38
38
Distress
32
32
Skin Inflammation
23
23
Fungal Infection
21
21
Irritation
21
21
Burning Sensation
17
17
Hypersensitivity/Allergic reaction
14
14
Fluid Discharge
14
14
Skin Tears
13
13
Tissue Breakdown
10
10
Ulcer
10
10
Laceration(s)
10
10
Urinary Tract Infection
9
9
Discharge
9
9
Blister
9
9
Inflammation
8
8
Reaction
8
8
No Code Available
8
8
Skin Erosion
7
7
Discomfort
6
6
Bacterial Infection
6
6
Unspecified Infection
4
4
Cellulitis
3
3
Purulent Discharge
3
3
Fungus
3
3
Pressure Sores
3
3
Increased Sensitivity
3
3
Urticaria
3
3
Foreign Body Reaction
2
2
Aspiration/Inhalation
2
2
Pneumonia
2
2
Ulceration
2
2
Wheal(s)
2
2
Skin Infection
2
2
Granuloma
2
2
Visual Disturbances
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
Oct-24-2022
2
Convatec Inc.
III
Oct-18-2010
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