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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
2021 2 2
2022 2 2
2023 2 2
2024 7 7
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Break 2 2
Off-Label Use 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 5 5
Perforation 4 4
Hematoma 3 3
Fever 3 3
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 3 3
Urinary Tract Infection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pneumothorax 2 2
Pericardial Effusion 2 2
Cardiac Tamponade 2 2
Sepsis 1 1
Urinary Incontinence 1 1
No Information 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Multiple Organ Failure 1 1
Cardiac Arrest 1 1
Post Operative Wound Infection 1 1
Cardiac Perforation 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Pleural Effusion 1 1
Laceration(s) 1 1
Prolapse 1 1
Asystole 1 1
Renal Failure 1 1
Perforation of Vessels 1 1

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