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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
2014 6 6
2015 5 5
2016 14 14
2017 33 33
2018 61 61
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 71 71
Product Quality Problem 48 48
Improper Chemical Reaction 45 45
Difficult to Insert 39 39
Component Misassembled 31 31
Fluid/Blood Leak 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Material Twisted/Bent 21 21
Patient-Device Incompatibility 21 21
Biocompatibility 18 18
Inaccurate Flow Rate 18 18
Nonstandard Device 17 17
Incorrect Measurement 17 17
Unintended Deflation 15 15
Material Integrity Problem 15 15
Leak/Splash 13 13
Defective Device 12 12
Deflation Problem 12 12
Misassembled 10 10
No Flow 10 10
Material Deformation 10 10
Gel Leak 9 9
Device Operates Differently Than Expected 9 9
Deformation Due to Compressive Stress 8 8
Partial Blockage 8 8
Material Rupture 7 7
Material Fragmentation 7 7
Sharp Edges 6 6
Detachment of Device or Device Component 6 6
Break 5 5
Bent 5 5
Contamination /Decontamination Problem 5 5
Structural Problem 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 4 4
Inadequacy of Device Shape and/or Size 4 4
Moisture or Humidity Problem 3 3
Obstruction of Flow 3 3
Shipping Damage or Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Component 3 3
Short Fill 3 3
Failure to Deflate 3 3
Kinked 3 3
Premature Separation 3 3
Inadequate Lubrication 3 3
Burst Container or Vessel 3 3
Material Split, Cut or Torn 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Known Impact Or Consequence To Patient 142 142
No Consequences Or Impact To Patient 122 122
Urinary Tract Infection 53 53
No Patient Involvement 45 45
Pain 17 17
Hemorrhage/Bleeding 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Patient Problem/Medical Problem 11 11
No Information 9 9
Discomfort 8 8
Insufficient Information 8 8
Unspecified Infection 6 6
Blood Loss 6 6
Foreign Body In Patient 6 6
No Code Available 5 5
Tissue Damage 4 4
Injury 3 3
Sepsis 2 2
Hematuria 2 2
Abrasion 2 2
Irritation 2 2
Urinary Retention 2 2
Skin Tears 2 2
Tissue Breakdown 2 2
Hypersensitivity/Allergic reaction 1 1
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
Burning Sensation 1 1
Exposure to Body Fluids 1 1
Reaction 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 Customed, Inc II Mar-21-2012
4 Go Medical Industries Pty., Ltd. II Oct-21-2011
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Nurse Assist, Inc II May-25-2011
9 Teleflex Medical III Aug-06-2014
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