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, ventricular (containing antibiotic or antimicrobial agents)
Definition Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Product CodeNHC
Regulation Number 882.4100
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 9 9
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8 8
Difficult to Remove 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
Device Embedded In Tissue or Plaque 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cerebrospinal Fluid Leakage 1 1
No Patient Involvement 1 1

-
-