BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARGLIDE EVH SMALL W/SCISSOR

    MDR report key: 2181529 · Received July 13, 2011

    Report

    Report Number
    1718850-2011-00077
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BIPOLAR DEVICE STARTED TO BURN THE VEIN NEAR THE TIP OF THE DEVICE AND CAUSED A BRUISE TO THE VEIN. THE PRODUCT HAS BEEN RETURNED TO SORIN GROUP (B)(4) AND AN INVESTIGATION IS BEING CONDUCTED. F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BIPOLAR DEVICE STARTED TO BURN THE VEIN NEAR THE TIP OF THE DEVICE AND CAUSED A BRUISE TO THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH SMALL W/SCISSOR BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1105200097

    Patients

    Seq Age Sex Outcome Treatment
    1