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 warmer, irrigation solution
Product CodeLHC
Regulation Number 890.5950
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 4 4
2021 5 5
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 7 7
Sharp Edges 5 5
Defective Device 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Mechanical Problem 1 1
No Apparent Adverse Event 1 1
Contamination /Decontamination Problem 1 1
Failure to Read Input Signal 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 5 5
Laceration(s) 4 4
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

-
-