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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device bag, urine collection, leg, for external use, sterile
Product CodeFAQ
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 1 1
2021 70 70
2022 48 48
2023 36 36
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 78 78
Component Missing 26 26
Biocompatibility 15 15
Deformation Due to Compressive Stress 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Component Misassembled 6 6
Material Twisted/Bent 4 4
Physical Resistance/Sticking 3 3
Nonstandard Device 3 3
Material Rupture 3 3
Obstruction of Flow 2 2
Patient-Device Incompatibility 2 2
Complete Blockage 2 2
Disconnection 2 2
No Flow 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Device Handling Problem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Illegible Information 1 1
Partial Blockage 1 1
Collapse 1 1
Inaccurate Flow Rate 1 1
Inadequate Instructions for Healthcare Professional 1 1
Incorrect Measurement 1 1
Fungus in Device Environment 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unexpected Therapeutic Results 1 1
Inadequate or Insufficient Training 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
Urinary Tract Infection 24 24
Sepsis 7 7
Urinary Retention 4 4
Discomfort 4 4
Unspecified Infection 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Consequences Or Impact To Patient 2 2
Skin Irritation 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Inflammation/ Irritation 1 1

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