• 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 dislodger, stone, flexible
Product CodeFGO
Regulation Number 876.4680
Device Class 2

MDR Year MDR Reports MDR Events
2017 17 17
2018 14 14
2019 25 25
2020 19 19
2021 14 14
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 35 35
Peeled/Delaminated 32 32
Difficult to Open or Close 17 17
Break 15 15
Material Deformation 5 5
Adverse Event Without Identified Device or Use Problem 3 3
Material Split, Cut or Torn 3 3
Difficult to Remove 3 3
Material Separation 2 2
Entrapment of Device 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 1 1
Material Twisted/Bent 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Difficult to Advance 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Degraded 1 1
Shipping Damage or Problem 1 1
Sticking 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 60 60
No Clinical Signs, Symptoms or Conditions 21 21
No Known Impact Or Consequence To Patient 10 10
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Discomfort 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Myocardial Infarction 1 1
Pain 1 1
Urinary Tract Infection 1 1
Injury 1 1
Hematuria 1 1
Unspecified Kidney or Urinary Problem 1 1

-
-