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 helmet, surgical
Product CodeFXZ
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 19 19
2016 9 9
2017 22 22
2018 13 13
2019 4 4
2020 4 4
2021 4 15
2022 4 4
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 78 89
Break 4 4
Device-Device Incompatibility 4 4
Leak/Splash 3 3
Smoking 3 3
Melted 2 2
Material Split, Cut or Torn 1 1
Fracture 1 3
Fire 1 1
Fitting Problem 1 1
Material Deformation 1 1
Electrical Shorting 1 1
Air Leak 1 1
Material Separation 1 1
Temperature Problem 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 38 38
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 17 17
No Clinical Signs, Symptoms or Conditions 16 27
Burn(s) 2 2
No Information 1 1
Burn, Thermal 1 1

-
-