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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
Tear, Rip or Hole in Device Packaging 5 5
Unsealed Device Packaging 5 5
Positioning Problem 4 4
Device Inoperable 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 3 3
Solder Joint Fracture 2 2
Bent 2 2
Mechanical Jam 2 2
Connection Problem 2 2
Failure to Discharge 1 1
Material Protrusion/Extrusion 1 1
Sticking 1 1
Detachment of Device or Device Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Device Damaged Prior to Use 1 1
Torn Material 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
Failure to Advance 1 1
Device Operates Differently Than Expected 1 1
Positioning Failure 1 1
Component Missing 1 1
Difficult to Insert 1 1
Misfire 1 1
Material Fragmentation 1 1
Radiation Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Output Problem 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 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
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