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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
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 394 394
Loss of or Failure to Bond 152 152
Difficult to Open or Close 73 73
Fitting Problem 66 66
Material Fragmentation 64 64
Detachment of Device or Device Component 43 43
Nonstandard Device 28 28
Device Slipped 27 27
Break 25 25
Loose or Intermittent Connection 19 19
Material Separation 19 19
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Physical Resistance/Sticking 9 9
Device Handling Problem 8 8
Patient Device Interaction Problem 7 7
Component Misassembled 6 6
Sharp Edges 6 6
Device Fell 6 6
Biocompatibility 6 6
Product Quality Problem 6 6
Incorrect Measurement 5 5
Mechanical Problem 5 5
Failure to Form Staple 5 5
Use of Device Problem 4 4
Defective Component 4 4
Component Missing 4 4
Patient-Device Incompatibility 4 4
Material Split, Cut or Torn 4 4
Appropriate Term/Code Not Available 3 3
Connection Problem 3 3
Fluid/Blood Leak 3 3
Malposition of Device 3 3
Structural Problem 2 2
Difficult to Remove 2 2
Activation, Positioning or Separation Problem 2 2
Deformation Due to Compressive Stress 2 2
Device Dislodged or Dislocated 2 2
Material Twisted/Bent 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 1
Illegible Information 1 1
Missing Information 1 1
Device Damaged by Another Device 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Improper Chemical Reaction 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Gel Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Display Difficult to Read 1 1
Expiration Date Error 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Inadequate or Insufficient Training 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 398 398
No Consequences Or Impact To Patient 380 380
No Known Impact Or Consequence To Patient 249 249
No Patient Involvement 13 13
Discomfort 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Insufficient Information 10 10
Pain 7 7
Urinary Tract Infection 6 6
Urinary Retention 5 5
Skin Tears 5 5
Skin Inflammation/ Irritation 4 4
Skin Irritation 4 4
Pressure Sores 3 3
Skin Discoloration 2 2
Inflammation 2 2
Erosion 2 2
Hypersensitivity/Allergic reaction 2 2
Patient Problem/Medical Problem 2 2
Blister 2 2
Irritability 2 2
Injury 1 1
Reaction 1 1
Tissue Breakdown 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Unspecified Infection 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1
Laceration(s) 1 1
Rash 1 1
Local Reaction 1 1
Swelling 1 1
Tissue Damage 1 1
Burning Sensation 1 1

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