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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGCC
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 2 2
2023 3 3
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Break 3 3
Burst Container or Vessel 1 1
Off-Label Use 1 1
Device Markings/Labelling Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
Perforation 2 2
Cardiac Tamponade 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Sepsis 1 1
Urinary Incontinence 1 1
No Information 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Pericardial Effusion 1 1
No Known Impact Or Consequence To Patient 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Cardiac Perforation 1 1
Fever 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
Urinary Tract Infection 1 1

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