BEUDAMED
    FDA Adverse Event Summary report: N

    SATINSKY CLAMP

    MDR report key: 680898 · Received March 2, 2006

    Report

    Report Number
    1044475-2006-00003
    Date Received
    March 2, 2006
    Date of Event
    January 10, 2006
    Report Date
    March 1, 2006
    Manufacturer
    QSA SURGICAL PVT LTD
    Product Code
    DXC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING THAT, "CLAMP BROKEN DURING HEPATIO TRANSPLANTATION, WHAT CAUSED A STRONG HEMORRHAGE." CLARIFICATION PROVIDED AS FOLLOWS: THE HEMMORRHAGING OCCURRED DUE TO HANDLE BREAKAGE CAUSING LOW BLOOD PRESSURE, HOSP STAY NOT EXTENDED DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATINSKY CLAMP VASCULAR CLAMP DXC QSA SURGICAL PVT LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other