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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device holder, ureteral catheter
Product CodeEYJ
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 13 13

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 67 67
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
Component Falling 14 14
Patient-Device Incompatibility 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
Malposition of Device 6 6
Biocompatibility 6 6
Failure to Form Staple 6 6
Device Dislodged or Dislocated 6 6
Kinked 6 6
Product Quality Problem 6 6
Component Misassembled 6 6
Sharp Edges 6 6
Appropriate Term/Code Not Available 5 5
Incorrect Measurement 5 5
Connection Problem 5 5
Defective Component 5 5
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 4 4
Material Twisted/Bent 4 4
Fluid/Blood Leak 4 4
Insufficient Information 4 4
Material Split, Cut or Torn 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
Naturally Worn 2 2
No Flow 2 2
Activation, Positioning or Separation Problem 2 2
Crack 2 2
Peeled/Delaminated 2 2
Difficult to Remove 2 2
Packaging Problem 2 2
Separation Problem 2 2
Illegible Information 1 1
Missing Information 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Material Puncture/Hole 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Leak/Splash 1 1
Positioning Failure 1 1
Component Incompatible 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Display Difficult to Read 1 1
Gel Leak 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Markings/Labelling Problem 1 1
Improper Chemical Reaction 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Material Protrusion/Extrusion 1 1
Device Damaged by Another Device 1 1
Expiration Date Error 1 1
Shipping Damage or Problem 1 1
Tear, Rip or Hole in Device Packaging 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 401 401
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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