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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, catheterization, sterile urethral, with or without catheter (kit)
Product CodeFCM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 79 79
2020 86 86
2021 85 85
2022 59 59
2023 48 48
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 47 47
Improper Chemical Reaction 45 45
Component Misassembled 31 31
Difficult to Insert 30 30
Product Quality Problem 23 23
Material Twisted/Bent 20 20
Fluid/Blood Leak 19 19
Biocompatibility 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Nonstandard Device 16 16
Unintended Deflation 15 15
Inaccurate Flow Rate 13 13
Incorrect Measurement 12 12
Patient-Device Incompatibility 11 11
Defective Device 9 9
Misassembled 9 9
Gel Leak 8 8
Material Integrity Problem 8 8
Deflation Problem 8 8
Material Fragmentation 7 7
Deformation Due to Compressive Stress 7 7
Material Rupture 7 7
Detachment of Device or Device Component 6 6
Sharp Edges 6 6
Leak/Splash 6 6
Material Deformation 6 6
Partial Blockage 5 5
No Flow 5 5
Inadequacy of Device Shape and/or Size 4 4
Break 4 4
Structural Problem 4 4
Contamination /Decontamination Problem 4 4
Failure to Deflate 3 3
Tear, Rip or Hole in Device Packaging 3 3
Shipping Damage or Problem 3 3
Material Split, Cut or Torn 3 3
Disconnection 3 3
Premature Separation 3 3
Insufficient Information 3 3
Inadequate Lubrication 3 3
Therapeutic or Diagnostic Output Failure 3 3
Burst Container or Vessel 3 3
Packaging Problem 2 2
Device Dislodged or Dislocated 2 2
Obstruction of Flow 2 2
Improper or Incorrect Procedure or Method 2 2
Material Protrusion/Extrusion 2 2
Difficult to Remove 2 2
Unsealed Device Packaging 2 2
Defective Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Consequences Or Impact To Patient 84 84
No Known Impact Or Consequence To Patient 81 81
Urinary Tract Infection 39 39
No Patient Involvement 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Pain 10 10
Patient Problem/Medical Problem 8 8
Insufficient Information 8 8
Hemorrhage/Bleeding 8 8
Discomfort 6 6
Unspecified Infection 5 5
No Code Available 5 5
Blood Loss 5 5
Foreign Body In Patient 5 5
Sepsis 2 2
Hematuria 2 2
Abrasion 2 2
Tissue Damage 2 2
Tissue Breakdown 2 2
Failure of Implant 1 1
Nausea 1 1
Urinary Incontinence 1 1
Skin Inflammation/ Irritation 1 1
Staphylococcus Aureus 1 1
Burn(s) 1 1
Injury 1 1
Exposure to Body Fluids 1 1
Urinary Retention 1 1
Skin Tears 1 1
Pressure Sores 1 1
Irritability 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Dec-02-2022
2 Cardinal Health 200, LLC I Feb-16-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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