Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, balloon type
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBA
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 27 27
2023 22 22
2024 16 16
2025 23 23
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 43 43
Material Rupture 15 15
Display or Visual Feedback Problem 15 15
Leak/Splash 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Material Puncture/Hole 5 5
No Visual Prompts/Feedback 3 3
Improper Flow or Infusion 3 3
Inflation Problem 3 3
Fracture 3 3
Component Missing 2 2
Deflation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Misassembled 1 1
Failure to Unfold or Unwrap 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
Stroke/CVA 3 3
Hemorrhage/Bleeding 3 3
Ischemia Stroke 3 3
Vascular Dissection 2 2
Vasoconstriction 2 2
Embolism/Embolus 2 2
Obstruction/Occlusion 2 2
Hemorrhagic Stroke 2 2
Transient Ischemic Attack 2 2
Hiccups 1 1
Dizziness 1 1
Hematoma 1 1
Inflammation 1 1
Perforation 1 1
Rupture 1 1
Intracranial Hemorrhage 1 1
Paralysis 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Discomfort 1 1
Insufficient Information 1 1
Choking 1 1
Perforation of Vessels 1 1
Feeding Problem 1 1
Loss of consciousness 1 1
Fistula 1 1

-
-