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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)
Regulation Description Laryngeal prosthesis (Taub design).
Product CodeEWL
Regulation Number 874.3730
Device Class 2

MDR Year MDR Reports MDR Events
2017 15 15
2019 7 7
2020 2 2
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 7 7
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Insufficient Information 5 5
Inadequacy of Device Shape and/or Size 3 3
Fluid Leak 3 3
Material Fragmentation 2 2
Leak/Splash 2 2
Migration or Expulsion of Device 2 2
Difficult to Remove 1 1
Material Rupture 1 1
Fracture 1 1
Break 1 1
Entrapment of Device 1 1
Missing Value Reason 1 1
Detachment of Device or Device Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aspiration/Inhalation 9 9
No Consequences Or Impact To Patient 8 8
Pneumonia 6 6
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Necrosis 1 1
Pain 1 1
Spinal Column Injury 1 1
Tissue Damage 1 1
Cellulitis 1 1
Death 1 1
Fistula 1 1
Foreign Body Reaction 1 1
Failure of Implant 1 1
Device Embedded In Tissue or Plaque 1 1
Swelling/ Edema 1 1
Post Operative Wound Infection 1 1

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