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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, tumor localization
Product CodeMIJ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 7 7
2020 3 3
2021 4 4
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 12 12
Migration 5 5
Break 4 4
Migration or Expulsion of Device 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 2 2
Use of Device Problem 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 9 9
No Code Available 9 9
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
No Patient Involvement 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Itching Sensation 1 1
Pain 1 1
Perforation 1 1
Pneumothorax 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Somatex Medical Technologies GMBH II Mar-10-2021
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