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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
Material Twisted/Bent 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Jam 2 2
Connection Problem 2 2
Solder Joint Fracture 2 2
Bent 2 2
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Component Missing 1 1
Positioning Failure 1 1
Material Fragmentation 1 1
Misfire 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Radiation Leak 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
Leak/Splash 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Fitting Problem 1 1
Failure to Discharge 1 1
Failure to Advance 1 1
Device Dislodged or Dislocated 1 1
Device Operates Differently Than Expected 1 1
Sticking 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 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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