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 system, applicator, radionuclide, manual
Product CodeIWJ
Regulation Number 892.5650
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 2 2
2017 7 7
2018 3 3
2019 5 5
2020 5 5
2021 15 15
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Physical Resistance/Sticking 6 6
Unsealed Device Packaging 5 5
Tear, Rip or Hole in Device Packaging 5 5
Positioning Problem 4 4
Device Inoperable 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 3 3
Mechanical Jam 2 2
Connection Problem 2 2
Solder Joint Fracture 2 2
Bent 2 2
Failure to Discharge 1 1
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Device Dislodged or Dislocated 1 1
Device Operates Differently Than Expected 1 1
Failure to Advance 1 1
Material Protrusion/Extrusion 1 1
Detachment of Device or Device Component 1 1
Sticking 1 1
Component Missing 1 1
Positioning Failure 1 1
Misfire 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Contamination /Decontamination Problem 1 1
Radiation Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Torn Material 1 1
Device Damaged Prior to Use 1 1
Output Problem 1 1
Malposition of Device 1 1
Entrapment of Device 1 1
Activation, Positioning or Separation Problem 1 1
Fitting Problem 1 1
Device Slipped 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 5 5
No Patient Involvement 4 4
Insufficient Information 2 2
Cancer 2 2
Radiation Exposure, Unintended 1 1
Missed Dose 1 1
No Information 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Device Technologies, Inc. II Jul-13-2010
2 Riverpoint Medical, LLC II Jan-10-2020
3 Riverpoint Medical, LLC III Jan-28-2019
4 Sirtex Medical Limited II Mar-18-2021
5 Theragenics Corporation II Dec-19-2018
6 Worldwide Medical Technologies, LLC II Oct-12-2011
-
-