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 retractor, fiberoptic
Product CodeFDG
Regulation Number 876.4530
Device Class 1

MDR Year MDR Reports MDR Events
2014 7 7
2015 5 5
2016 7 7
2017 5 5
2018 3 3
2019 3 3
2020 3 3
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 6 6
Melted 5 5
Break 5 5
Smoking 4 4
Temperature Problem 4 4
Insufficient Information 3 3
Use of Device Problem 3 3
Device Operates Differently Than Expected 3 3
Component Falling 3 3
Thermal Decomposition of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Power Problem 2 2
Device Dislodged or Dislocated 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Fumes or Vapors 1 1
Crack 1 1
Material Frayed 1 1
Accessory Incompatible 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 10 10
No Known Impact Or Consequence To Patient 7 7
Burn, Thermal 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Partial thickness (Second Degree) Burn 3 3
No Code Available 2 2
No Consequences Or Impact To Patient 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Injury 1 1
Laceration(s) of Esophagus 1 1
Erythema 1 1
Blister 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Lumitex Inc II Sep-03-2009
-
-