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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, incontinence, urosheath type, non-sterile
Definition Urine collector and accessories; see product code EXJ
Product CodeNNX
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 12 12
2017 109 109
2018 147 147
2019 131 131
2020 180 180
2021 148 148
2022 111 111
2023 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 525 525
Difficult to Remove 144 144
Adverse Event Without Identified Device or Use Problem 57 57
Physical Resistance/Sticking 49 49
Material Integrity Problem 47 47
Biocompatibility 43 43
Device Operates Differently Than Expected 41 41
Sticking 33 33
Patient-Device Incompatibility 32 32
Product Quality Problem 30 30
Component Missing 18 18
Inadequate Instructions for Healthcare Professional 17 17
Material Deformation 15 15
Device Markings/Labelling Problem 13 13
Loss of or Failure to Bond 13 13
Defective Device 12 12
Inadequacy of Device Shape and/or Size 11 11
Inaccurate Flow Rate 11 11
Insufficient Information 11 11
Patient Device Interaction Problem 10 10
Material Too Rigid or Stiff 10 10
Appropriate Term/Code Not Available 8 8
Therapeutic or Diagnostic Output Failure 8 8
Missing Information 7 7
Leak/Splash 6 6
Failure To Adhere Or Bond 5 5
Labelling, Instructions for Use or Training Problem 5 5
Mechanical Problem 5 5
Expiration Date Error 5 5
Device Contamination with Chemical or Other Material 5 5
Material Twisted/Bent 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Handling Problem 5 5
Structural Problem 4 4
Defective Component 4 4
Inadequate or Insufficient Training 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Fluid/Blood Leak 4 4
Difficult to Fold, Unfold or Collapse 3 3
Backflow 3 3
Detachment Of Device Component 3 3
Shipping Damage or Problem 3 3
Output above Specifications 3 3
Detachment of Device or Device Component 3 3
Infusion or Flow Problem 3 3
Sharp Edges 3 3
Illegible Information 3 3
Component Misassembled 2 2
Physical Property Issue 2 2
No Flow 2 2
Output Problem 2 2
Improper Flow or Infusion 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Incorrect Device Or Component Shipped 2 2
Deformation Due to Compressive Stress 2 2
Split 2 2
Obstruction of Flow 2 2
Fitting Problem 2 2
Incorrect Measurement 2 2
Restricted Flow rate 2 2
Accessory Incompatible 1 1
Hole In Material 1 1
Positioning Failure 1 1
Collapse 1 1
Partial Blockage 1 1
Bent 1 1
Material Rupture 1 1
Peeled/Delaminated 1 1
Decrease in Pressure 1 1
Retraction Problem 1 1
Occlusion Within Device 1 1
High Test Results 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1
Separation Failure 1 1
Contamination /Decontamination Problem 1 1
Improper Chemical Reaction 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Open or Close 1 1
Failure of Device to Self-Test 1 1
Packaging Problem 1 1
Measurement System Incompatibility 1 1
Pressure Problem 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Material Too Soft/Flexible 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 274 274
No Known Impact Or Consequence To Patient 225 225
No Clinical Signs, Symptoms or Conditions 181 181
Pain 92 92
Urinary Tract Infection 73 73
Skin Tears 58 58
Skin Inflammation/ Irritation 39 39
No Information 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
No Patient Involvement 24 24
Discomfort 23 23
Skin Irritation 22 22
Unspecified Infection 21 21
Patient Problem/Medical Problem 15 15
No Code Available 15 15
Irritation 13 13
Injury 13 13
Pressure Sores 12 12
Tissue Breakdown 12 12
Abrasion 11 11
Skin Discoloration 9 9
Tissue Damage 9 9
Hemorrhage/Bleeding 8 8
Erythema 7 7
Bruise/Contusion 7 7
Rash 7 7
Swelling 5 5
Blood Loss 5 5
Urinary Retention 4 4
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 3 3
Reaction 3 3
Foreign Body In Patient 3 3
Hematuria 3 3
Complaint, Ill-Defined 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Excessive Tear Production 2 2
Burning Sensation 2 2
Adhesion(s) 2 2
Peeling 2 2
Itching Sensation 2 2
Inflammation 1 1
Local Reaction 1 1
Cyanosis 1 1
Edema 1 1
Incontinence 1 1
Fever 1 1
Head Injury 1 1
Skin Erosion 1 1
Ulcer 1 1
Fungal Infection 1 1
Irritability 1 1
Blister 1 1
Localized Skin Lesion 1 1

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