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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, retention, barium enema with bag
Product CodeFGD
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
CHESS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 1 1
Pain 1 1
Injury 1 1
Skin Tears 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Embolism/Embolus 1 1
Skin Inflammation/ Irritation 1 1

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