inforMED
InjuryPLJ

LIQUIFIX FIX8

Received Jan 6, 2025

Report 9617175-2025-00001 · MDR key 21080269

Device

Generic name

Hernia Mesh Fixation

Model number

72014032

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Hematoma
  • Hematoma

Narrative

Description of Event or Problem

ACCORDING TO THE REPORT: DURING THE INTERIM PROGRESS REPORT OF OUR US CLINICAL STUDY, A RE-ADMISSION AND RE-OPERATION FOR BLEEDING COMPLICATION WAS REPORTED WITHIN THE 30 DAY OUTCOMES. THE PATIENT WAS READMITTED EMERGENTLY AND REOPERATION WAS PERFORMED. A HEMATOMA WAS FOUND IN THE RETROPERITONEUM AND WASHED OUT. THE FLAP CLOSURE WAS INTACT AT THE TIME AND TAKEN DOWN TO EVACUATE THE HEMATOMA. THE FLAP WAS RECLOSED USING A PERMANENT TACKER DEVICE. THE PATIENT WAS ADMITTED OVERNIGHT AND SENT HOME. AS IT IS REPORTED VIA A REGISTRY, SPECIFIC PATIENT DETAILS AND/OR SITE WAS NOT REPORTED. EXCEPT THAT IT IS IN THE USA AND IT IS THE LIQUIFIX FIX8 72014032 DEVICE.

Additional Manufacturer Narrative

PATIENT DETAILS WERE NOT PROVIDED FROM THE REPORTER. INFORMATION IS LIMITED AS THIS IS REPORTED THIRD PARTY VIA A REGISTRY.