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TPLC
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Device
protector, ostomy
Regulation Description
Ostomy pouch and accessories.
Product Code
EXE
Regulation Number
876.5900
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
8667
8667
2021
1144
1144
2022
547
547
2023
360
360
2024
295
295
2025
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Malposition of Device
10498
10498
Positioning Problem
1359
1359
Fluid/Blood Leak
525
525
Material Too Rigid or Stiff
171
171
Material Disintegration
135
135
Adverse Event Without Identified Device or Use Problem
92
92
Sharp Edges
67
67
Material Erosion
53
53
Complete Blockage
34
34
Device Handling Problem
33
33
Leak/Splash
32
32
Melted
24
24
Material Protrusion/Extrusion
22
22
Material Split, Cut or Torn
21
21
Partial Blockage
20
20
Material Separation
18
18
Improper or Incorrect Procedure or Method
18
18
Physical Resistance/Sticking
14
14
Activation, Positioning or Separation Problem
13
13
Separation Problem
13
13
Obstruction of Flow
12
12
Material Too Soft/Flexible
10
10
Off-Label Use
7
7
Flare or Flash
7
7
Insufficient Information
4
4
Fire
2
2
Device Dislodged or Dislocated
1
1
Unintended Movement
1
1
Packaging Problem
1
1
Device Emits Odor
1
1
Crack
1
1
Material Integrity Problem
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
5673
5673
No Patient Involvement
2711
2711
No Clinical Signs, Symptoms or Conditions
1875
1875
Tissue Breakdown
253
253
Tissue Damage
188
188
Hemorrhage/Bleeding
183
183
Erythema
141
141
Blood Loss
141
141
Skin Inflammation/ Irritation
134
134
Skin Irritation
123
123
Laceration(s)
106
106
Discomfort
92
92
Pain
60
60
Obstruction/Occlusion
47
47
Distress
30
30
Blister
29
29
Fungal Infection
26
26
Rash
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Cramp(s) /Muscle Spasm(s)
20
20
Itching Sensation
15
15
Abrasion
14
14
Ulcer
13
13
Skin Tears
12
12
Skin Infection
11
11
Unspecified Infection
11
11
Hypersensitivity/Allergic reaction
10
10
Fluid Discharge
9
9
Urinary Tract Infection
9
9
Burning Sensation
8
8
Bacterial Infection
8
8
Anxiety
7
7
Necrosis
7
7
Injury
6
6
Pressure Sores
6
6
Burn(s)
6
6
Cellulitis
6
6
Urinary Retention
6
6
Bruise/Contusion
5
5
Swelling/ Edema
5
5
Inflammation
4
4
Contact Dermatitis
4
4
Urticaria
3
3
Purulent Discharge
3
3
Skin Discoloration
3
3
Irritation
3
3
Reaction
2
2
Abdominal Distention
2
2
Discharge
2
2
Superficial (First Degree) Burn
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
Jan-10-2025
2
ConvaTec, Inc
II
May-25-2022
3
T.G. Eakin Limited
III
Sep-25-2024
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