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 bottle, hot/cold water
Product CodeFPF
Regulation Number 880.6085
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 2 2
2019 3 3
2020 1 1
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 3 3
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Rupture 2 2
Burst Container or Vessel 1 1
Fluid/Blood Leak 1 1
Output Problem 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 9 9
Weight Changes 3 3
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Burn, Thermal 1 1

-
-