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 tamp
Product CodeHXG
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 8 8
2021 7 7
2022 5 5
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 15 15
Break 11 11
Leak/Splash 5 5
Device-Device Incompatibility 3 3
Material Deformation 3 3
Naturally Worn 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
Inflation Problem 1 1
Burst Container or Vessel 1 1
Crack 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 3 3
Extravasation 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Bone Fracture(s) 1 1
Foreign Body In Patient 1 1

-
-