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 mask, gas, anesthetic
Product CodeBSJ
Regulation Number 868.5550
Device Class 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 1 1
2021 11 11
2022 11 11
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 6 6
Material Deformation 6 6
Inflation Problem 4 4
Leak/Splash 2 2
Break 2 2
Crack 2 2
Patient-Device Incompatibility 2 2
Material Puncture/Hole 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unexpected Color 2 2
Unintended Deflation 1 1
Device Fell 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Filtration Problem 1 1
Human-Device Interface Problem 1 1
Deflation Problem 1 1
Material Discolored 1 1
Filling Problem 1 1
Gas Output Problem 1 1
Intermittent Continuity 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 4 4
Respiratory Distress Syndrome of Newborns 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blister 2 2
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Insufficient Information 1 1
Low Oxygen Saturation 1 1
No Patient Involvement 1 1

-
-