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 instrument, cast removal, ac-powered
Product CodeLGH
Regulation Number 888.5960
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 4 4
2016 2 2
2017 1 1
2018 8 8
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Dull, Blunt 3 3
Cut In Material 1 1
Failure to Cut 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Electrical /Electronic Property Problem 1 1
Fracture 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Patient Involvement 4 4
Abrasion 4 4
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

-
-