• 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 esophageal dilator with balloon and electrode sensors
Definition To dilate esophageal strictures with a dilating balloon and electrode sensors.
Product CodePIE
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Esophagus 5 5
Radiation Exposure, Unintended 3 3
No Code Available 2 2
Chest Pain 2 2
Pain 2 2
Abdominal Pain 1 1
Death 1 1
Breast Cancer 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Perforation 1 1
Pyrosis/Heartburn 1 1
Laceration(s) of Esophagus 1 1
Blood Loss 1 1
Vomiting 1 1
Dysphagia/ Odynophagia 1 1
Stenosis 1 1
Excessive Tear Production 1 1

-
-