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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, intrauterine, contraceptive and introducer
Definition Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Product CodeHDT
Regulation Number 884.5360
Device Class 3

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2018 1 1
2019 3 3
2020 4 4
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Component Missing 4 4
Detachment of Device or Device Component 4 4
Migration or Expulsion of Device 2 2
Defective Component 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Pain 1 1
Renal Failure 1 1
Scar Tissue 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1

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