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TPLC
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Device
holder, ureteral catheter
Product Code
EYJ
Regulation Number
876.5130
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
2
2
2016
2
2
2017
117
117
2018
182
182
2019
157
157
2020
234
234
2021
176
176
2022
118
118
2023
98
98
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disconnection
488
488
Loss of or Failure to Bond
180
180
Difficult to Open or Close
121
121
Fitting Problem
102
102
Material Fragmentation
64
64
Detachment of Device or Device Component
57
57
Break
46
46
Device Slipped
37
37
Failure To Adhere Or Bond
31
31
Nonstandard Device
30
30
Loose or Intermittent Connection
26
26
Device Operates Differently Than Expected
26
26
Material Separation
25
25
Detachment Of Device Component
21
21
Adverse Event Without Identified Device or Use Problem
15
15
Patient-Device Incompatibility
14
14
Component Falling
14
14
Mechanical Problem
11
11
Positioning Problem
10
10
Physical Resistance/Sticking
10
10
Device Fell
10
10
Therapeutic or Diagnostic Output Failure
9
9
Defective Device
9
9
Device Handling Problem
8
8
Patient Device Interaction Problem
7
7
Use of Device Problem
7
7
Component Missing
6
6
Device Dislodged or Dislocated
6
6
Component Misassembled
6
6
Product Quality Problem
6
6
Failure to Form Staple
6
6
Biocompatibility
6
6
Sharp Edges
6
6
Malposition of Device
6
6
Kinked
6
6
Defective Component
5
5
Connection Problem
5
5
Incorrect Measurement
5
5
Appropriate Term/Code Not Available
5
5
Material Split, Cut or Torn
4
4
Improper or Incorrect Procedure or Method
4
4
Material Integrity Problem
4
4
Material Twisted/Bent
4
4
Insufficient Information
4
4
Fluid/Blood Leak
4
4
Unintended Movement
3
3
Inadequacy of Device Shape and/or Size
3
3
Structural Problem
3
3
Deformation Due to Compressive Stress
2
2
Activation, Positioning or Separation Problem
2
2
No Flow
2
2
Difficult to Remove
2
2
Peeled/Delaminated
2
2
Packaging Problem
2
2
Crack
2
2
Naturally Worn
2
2
Separation Problem
2
2
Labelling, Instructions for Use or Training Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Gel Leak
1
1
Device Markings/Labelling Problem
1
1
Material Rupture
1
1
Mechanics Altered
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper Chemical Reaction
1
1
Difficult to Insert
1
1
Leak/Splash
1
1
Incomplete or Inadequate Connection
1
1
Material Deformation
1
1
Sticking
1
1
Material Protrusion/Extrusion
1
1
Positioning Failure
1
1
Inadequate or Insufficient Training
1
1
Complete Blockage
1
1
Unexpected Shutdown
1
1
Component Incompatible
1
1
Device Damaged by Another Device
1
1
Illegible Information
1
1
Inflation Problem
1
1
Expiration Date Error
1
1
Burst Container or Vessel
1
1
Migration or Expulsion of Device
1
1
Infusion or Flow Problem
1
1
Display Difficult to Read
1
1
Missing Information
1
1
Device Inoperable
1
1
Tear, Rip or Hole in Device Packaging
1
1
Compatibility Problem
1
1
No Apparent Adverse Event
1
1
Material Puncture/Hole
1
1
Shipping Damage or Problem
1
1
Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
518
518
No Known Impact Or Consequence To Patient
451
451
No Clinical Signs, Symptoms or Conditions
398
398
No Information
41
41
No Patient Involvement
22
22
Discomfort
16
16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Insufficient Information
10
10
Pain
10
10
Injury
8
8
Pressure Sores
7
7
Skin Tears
7
7
Urinary Retention
7
7
Urinary Tract Infection
7
7
Skin Irritation
6
6
Tissue Damage
4
4
Skin Inflammation/ Irritation
4
4
Hemorrhage/Bleeding
3
3
Hypersensitivity/Allergic reaction
2
2
Unspecified Infection
2
2
Inflammation
2
2
Irritation
2
2
Itching Sensation
2
2
Erosion
2
2
Erythema
2
2
Skin Discoloration
2
2
Swelling
2
2
Reaction
2
2
Irritability
2
2
Blood Loss
2
2
Patient Problem/Medical Problem
2
2
No Code Available
2
2
Blister
2
2
Unspecified Tissue Injury
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Tissue Breakdown
1
1
Skin Inflammation
1
1
Hematuria
1
1
Vascular System (Circulation), Impaired
1
1
Inadequate Pain Relief
1
1
Rash
1
1
Local Reaction
1
1
Burning Sensation
1
1
Abscess
1
1
Purulent Discharge
1
1
Laceration(s)
1
1
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