BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAPASS

    MDR report key: 10809507 · Received November 9, 2020

    Report

    Report Number
    3005753386-2020-00001
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    March 11, 2020
    Report Date
    November 9, 2020
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN TIGHTENING THE LIGAPASS BAND, THE TENSIONER'S PLIERS CAN CRUSH THE BAND, CAUSING THE BAND TO BREAK DURING SURGERY. THIS ADVERSE EVENT OCCURING IN MARCH AND LED TO LONGER OPERATING TIME, INFECTION AND RE-INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278514 LIGAPASS LIGAPASS TENSIONPULLEY XS LXH MEDICREA INTERNATIONAL A08200200 19B0595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention