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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, laryngeal (taub)
Product CodeEWL
Regulation Number 874.3730
Device Class 2

MDR Year MDR Reports MDR Events
2019 7 7
2020 2 2
2021 7 7
2022 5 5
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 6 6
Fluid/Blood Leak 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Dislodged or Dislocated 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Biofilm coating in Device 2 2
Break 2 2
Migration or Expulsion of Device 2 2
Material Fragmentation 2 2
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Fracture 1 1
Insufficient Information 1 1
Device Fell 1 1
Positioning Problem 1 1
Defective Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Rupture 1 1
Entrapment of Device 1 1
Material Protrusion/Extrusion 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 8 8
Aspiration/Inhalation 6 6
Pneumonia 4 4
No Consequences Or Impact To Patient 3 3
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Infection 1 1
Failure of Implant 1 1
Necrosis 1 1
Bowel Perforation 1 1
Spinal Column Injury 1 1
Foreign Body Reaction 1 1
Cellulitis 1 1
Post Operative Wound Infection 1 1
Pain 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Fistula 1 1

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