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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
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 417 417
Difficult to Remove 67 67
Adverse Event Without Identified Device or Use Problem 50 50
Biocompatibility 43 43
Physical Resistance/Sticking 41 41
Product Quality Problem 19 19
Material Integrity Problem 16 16
Patient-Device Incompatibility 16 16
Loss of or Failure to Bond 14 14
Inadequate Instructions for Healthcare Professional 13 13
Patient Device Interaction Problem 11 11
Defective Device 11 11
Material Deformation 11 11
Inaccurate Flow Rate 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Markings/Labelling Problem 8 8
Inadequacy of Device Shape and/or Size 8 8
Component Missing 8 8
Material Too Rigid or Stiff 7 7
Missing Information 7 7
Leak/Splash 6 6
Device Handling Problem 5 5
Material Twisted/Bent 5 5
Fluid/Blood Leak 4 4
Inadequate or Insufficient Training 4 4
Expiration Date Error 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Use of Device Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Defective Component 3 3
Insufficient Information 3 3
Backflow 3 3
Illegible Information 3 3
Labelling, Instructions for Use or Training Problem 3 3
Sharp Edges 3 3
Detachment of Device or Device Component 2 2
Appropriate Term/Code Not Available 2 2
Component Misassembled 2 2
Fitting Problem 2 2
Obstruction of Flow 2 2
Restricted Flow rate 2 2
Shipping Damage or Problem 2 2
Infusion or Flow Problem 2 2
Structural Problem 2 2
Deformation Due to Compressive Stress 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
No Apparent Adverse Event 1 1
Device Contamination with Body Fluid 1 1
Incomplete or Missing Packaging 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 191 191
No Clinical Signs, Symptoms or Conditions 181 181
No Known Impact Or Consequence To Patient 109 109
Pain 65 65
Urinary Tract Infection 62 62
Skin Tears 44 44
Skin Inflammation/ Irritation 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Unspecified Infection 20 20
Skin Irritation 14 14
Patient Problem/Medical Problem 13 13
Tissue Breakdown 13 13
Discomfort 12 12
Abrasion 10 10
Irritation 10 10
No Patient Involvement 10 10
No Code Available 8 8
Pressure Sores 8 8
Skin Discoloration 7 7
Rash 5 5
Injury 5 5
Hypersensitivity/Allergic reaction 4 4
Bruise/Contusion 4 4
Erythema 4 4
Swelling 4 4
Hemorrhage/Bleeding 3 3
Tissue Damage 3 3
Swelling/ Edema 3 3
Reaction 3 3
Hematuria 3 3
Insufficient Information 2 2
Blood Loss 2 2
Bacterial Infection 2 2
No Information 2 2
Urinary Retention 1 1
Burning Sensation 1 1
Laceration(s) 1 1
Fever 1 1
Localized Skin Lesion 1 1
Blister 1 1
Local Reaction 1 1
Itching Sensation 1 1
Adhesion(s) 1 1
Irritability 1 1
Fungal Infection 1 1
Complaint, Ill-Defined 1 1
Excessive Tear Production 1 1

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