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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, laryngectomy
Product CodeKAC
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 1 1
2017 1 1
2019 1 1
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 2 2
Entrapment of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Material Puncture/Hole 2 2
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1
Contamination /Decontamination Problem 1 1
Gas/Air Leak 1 1
Loose or Intermittent Connection 1 1
Material Rupture 1 1
Defective Device 1 1
Break 1 1
Device Slipped 1 1
Inadequate User Interface 1 1
Improper Flow or Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Aspiration/Inhalation 1 1
Dyspnea 1 1
Respiratory Distress 1 1

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