BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIFIX FIX8

    MDR report key: 21080269 · Received January 6, 2025

    Report

    Report Number
    9617175-2025-00001
    Event Type
    Injury
    Date Received
    January 6, 2025
    Report Date
    January 6, 2025
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD
    Product Code
    PLJ
    PMA / PMN Number
    P220024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972411 LIQUIFIX FIX8 HERNIA MESH FIXATION PLJ ADVANCED MEDICAL SOLUTIONS (PLYMOIUTH) LTD 72014032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention