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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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 5 5
No Patient Involvement 4 4
Cancer 2 2
Insufficient Information 2 2
Radiation Exposure, Unintended 1 1
No Information 1 1
Tissue Damage 1 1
Missed Dose 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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