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 pack, heat, moist
Product CodeIMA
Regulation Number 890.5730
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1
Skin Irritation 1 1
Burning Sensation 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bruder Healthcare Company, LLC II Mar-22-2024
-
-