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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound drain catheter system
Definition For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Product CodeOTK
Regulation Number 878.4780
Device Class 2


Premarket Reviews
ManufacturerDecision
CLEARFLOW, INC,
  SUBSTANTIALLY EQUIVALENT 1
CLEARFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 9 9
2021 3 3
2022 7 7
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 14 14
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 1 1
Restricted Flow rate 1 1
Suction Failure 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 4 4
Hemorrhage/Bleeding 3 3
Device Embedded In Tissue or Plaque 2 2
Death 1 1
No Information 1 1
Foreign Body In Patient 1 1
Bradycardia 1 1
Hemothorax 1 1

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