BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY HYDRAGRIP CLAMP

    MDR report key: 73075 · Received March 5, 1997

    Report

    Report Number
    1423537-1997-00037
    Event Type
    Injury
    Date Received
    March 5, 1997
    Date of Event
    October 3, 1996
    Report Date
    March 5, 1997
    Manufacturer
    SITE 192369-V. MUELLER/SURGICAL GROUP
    Product Code
    DXC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A MITRAL VALVE REPAIR A FOREIGN BODY WAS DETECTED ON THE PT'S X-RAY. THE FOREIGN BODY WAS A CLAMP INSERT AND SURGICAL INTERVENTION WAS REQUIRED IN ORDER TO RETRIEVE THE INSERT. FIVE CLAMPS WERE RETURNED AND THE HOSPITAL IS UNSURE AS TO WHICH CLAMP WAS ACTUALLY IMPLICATED. CV5040 AND CV5045 CLAMPS WERE IN USE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY HYDRAGRIP CLAMP VASCULAR CLAMP DXC SITE 192369-V. MUELLER/SURGICAL GROUP CV5045 LB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention