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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
2024 5 5

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
Loss of or Failure to Bond 15 15
Device Markings/Labelling Problem 13 13
Defective Device 12 12
Inaccurate Flow Rate 11 11
Inadequacy of Device Shape and/or Size 11 11
Patient Device Interaction Problem 11 11
Insufficient Information 11 11
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
Fluid/Blood Leak 6 6
Leak/Splash 6 6
Expiration Date Error 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Failure To Adhere Or Bond 5 5
Mechanical Problem 5 5
Labelling, Instructions for Use or Training Problem 5 5
Device Handling Problem 5 5
Material Twisted/Bent 5 5
Defective Component 4 4
Inadequate or Insufficient Training 4 4
Improper or Incorrect Procedure or Method 4 4
Use of Device Problem 4 4
Structural Problem 4 4
Detachment of Device or Device Component 3 3
Output above Specifications 3 3
Illegible Information 3 3
Difficult to Fold, Unfold or Collapse 3 3
Shipping Damage or Problem 3 3
Backflow 3 3
Detachment Of Device Component 3 3
Sharp Edges 3 3
Infusion or Flow Problem 3 3
Component Misassembled 2 2
Deformation Due to Compressive Stress 2 2

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 41 41
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
Tissue Breakdown 14 14
Irritation 13 13
Injury 13 13
Pressure Sores 12 12
Abrasion 11 11
Tissue Damage 9 9
Skin Discoloration 9 9
Hemorrhage/Bleeding 8 8
Bruise/Contusion 7 7
Rash 7 7
Erythema 7 7
Blood Loss 5 5
Swelling 5 5
Hypersensitivity/Allergic reaction 4 4
Urinary Retention 4 4
Hematuria 3 3
Swelling/ Edema 3 3
Reaction 3 3
Foreign Body In Patient 3 3
Laceration(s) 3 3
Excessive Tear Production 2 2
Bacterial Infection 2 2
Peeling 2 2
Insufficient Information 2 2
Burning Sensation 2 2
Itching Sensation 2 2
Adhesion(s) 2 2
Complaint, Ill-Defined 2 2
Skin Erosion 1 1
Fever 1 1
Incontinence 1 1
Localized Skin Lesion 1 1
Blister 1 1
Local Reaction 1 1
Ulcer 1 1

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