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 light, headband, surgical
Product CodeFSR
Regulation Number 886.4335
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1
2019 2 2
2020 13 13
2021 14 14
2022 11 11
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 16 16
Electrical Shorting 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Sparking 4 4
Intermittent Loss of Power 3 3
Temperature Problem 3 3
Device Emits Odor 2 2
Smoking 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Environmental Compatibility Problem 1 1
Environmental Particulates 1 1
Material Integrity Problem 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1
Ambient Temperature Problem 1 1
Connection Problem 1 1
Optical Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Known Impact Or Consequence To Patient 9 9
Headache 9 9
No Consequences Or Impact To Patient 5 5
Pain 3 3
Erythema 1 1

-
-