inforMED
InjuryOTK

PLEURAFLOW SYSTEM WITH FLOWGLIDE

Received Sep 6, 2022 · Event occurred Aug 9, 2022

Report 3008782989-2022-00001 · MDR key 15364541

Device

Generic name

Chest Tube

Manufacturer

Clearflow, Inc.

Model number

PFFG3-24-RA

Catalog number

PFFG3-24-RA

Lot number

1053701

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

59 YR · Male

  • Hemothorax
  • Hemothorax

Narrative

Description of Event or Problem

PATIENT EXPERIENCED LEFT HEMOTHORAX.

Additional Manufacturer Narrative

IT IS NOT DEMONSTRATED THAT THE DEVICE PERFORMANCE IS ASSOCIATED WITH THE OUTCOME, HEMOTHORAX. THE PATIENT WAS RECOVERED UPON THE MEDICAL INTERVENTION.