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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bougie, esophageal, and gastrointestinal, gastro-urology
Regulation Description Esophageal dilator.
Product CodeFAT
Regulation Number 876.5365
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2023 1 1
2024 3 3
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 3 3
Detachment of Device or Device Component 2 2
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Chemical Exposure 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Sore Throat 1 1

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