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TPLC
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Device
device, incontinence, urosheath type, non-sterile
Definition
Urine collector and accessories; see product code EXJ
Product Code
NNX
Regulation Number
876.5250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
12
12
2017
109
109
2018
147
147
2019
131
131
2020
180
180
2021
148
148
2022
111
111
2023
44
44
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
525
525
Difficult to Remove
144
144
Adverse Event Without Identified Device or Use Problem
57
57
Physical Resistance/Sticking
49
49
Material Integrity Problem
47
47
Biocompatibility
43
43
Device Operates Differently Than Expected
41
41
Sticking
33
33
Patient-Device Incompatibility
32
32
Product Quality Problem
30
30
Component Missing
18
18
Inadequate Instructions for Healthcare Professional
17
17
Loss of or Failure to Bond
15
15
Material Deformation
15
15
Device Markings/Labelling Problem
13
13
Defective Device
12
12
Inadequacy of Device Shape and/or Size
11
11
Inaccurate Flow Rate
11
11
Insufficient Information
11
11
Patient Device Interaction Problem
11
11
Material Too Rigid or Stiff
10
10
Appropriate Term/Code Not Available
8
8
Therapeutic or Diagnostic Output Failure
8
8
Missing Information
7
7
Fluid/Blood Leak
6
6
Leak/Splash
6
6
Device Contamination with Chemical or Other Material
5
5
Labelling, Instructions for Use or Training Problem
5
5
Material Twisted/Bent
5
5
Failure To Adhere Or Bond
5
5
Expiration Date Error
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Device Handling Problem
5
5
Mechanical Problem
5
5
Improper or Incorrect Procedure or Method
4
4
Inadequate or Insufficient Training
4
4
Defective Component
4
4
Use of Device Problem
4
4
Structural Problem
4
4
Detachment Of Device Component
3
3
Illegible Information
3
3
Output above Specifications
3
3
Detachment of Device or Device Component
3
3
Shipping Damage or Problem
3
3
Difficult to Fold, Unfold or Collapse
3
3
Infusion or Flow Problem
3
3
Sharp Edges
3
3
Backflow
3
3
Deformation Due to Compressive Stress
2
2
No Flow
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
274
274
No Known Impact Or Consequence To Patient
225
225
No Clinical Signs, Symptoms or Conditions
181
181
Pain
92
92
Urinary Tract Infection
73
73
Skin Tears
58
58
Skin Inflammation/ Irritation
41
41
No Information
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
28
28
No Patient Involvement
24
24
Discomfort
23
23
Skin Irritation
22
22
Unspecified Infection
21
21
Patient Problem/Medical Problem
15
15
No Code Available
15
15
Tissue Breakdown
14
14
Irritation
13
13
Injury
13
13
Pressure Sores
12
12
Abrasion
11
11
Tissue Damage
9
9
Skin Discoloration
9
9
Hemorrhage/Bleeding
8
8
Bruise/Contusion
7
7
Rash
7
7
Erythema
7
7
Blood Loss
5
5
Swelling
5
5
Hypersensitivity/Allergic reaction
4
4
Urinary Retention
4
4
Hematuria
3
3
Swelling/ Edema
3
3
Reaction
3
3
Foreign Body In Patient
3
3
Laceration(s)
3
3
Excessive Tear Production
2
2
Bacterial Infection
2
2
Peeling
2
2
Insufficient Information
2
2
Burning Sensation
2
2
Itching Sensation
2
2
Adhesion(s)
2
2
Complaint, Ill-Defined
2
2
Skin Erosion
1
1
Fever
1
1
Incontinence
1
1
Localized Skin Lesion
1
1
Blister
1
1
Local Reaction
1
1
Ulcer
1
1
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