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 ring, teething, non-fluid filled
Product CodeMEF
Regulation Number 872.5550
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4 4
Break 3 3
Product Quality Problem 3 3
Material Fragmentation 2 2
Material Puncture/Hole 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Scratched Material 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
Choking 2 2
Foreign Body In Patient 2 2
Dyspnea 1 1
Strangulation 1 1
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

-
-