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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, muscle, pectoralis
Product CodeMIC
Regulation Number 874.3620
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 1 1
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Malposition of Device 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Migration 1 1
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Necrosis 2 2
Seroma 2 2
No Code Available 1 1
No Information 1 1
Rash 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

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