• 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 patient examination glove
Product CodeFMC
Regulation Number 880.6250
Device Class 1

MDR Year MDR Reports MDR Events
2017 32 32
2019 1 1
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Torn Material 24 24
Material Integrity Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Hole In Material 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Crack 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Emits Odor 1 1
Patient-Device Incompatibility 1 1
Product Quality Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
Reaction 3 3
No Patient Involvement 2 2
Insufficient Information 2 2
Chemical Exposure 1 1
No Information 1 1
Exposure to Body Fluids 1 1
Inflammation 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Swelling 1 1
Injury 1 1

-
-