BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, EVH

    MDR report key: 2861289 · Received December 5, 2012

    Report

    Report Number
    1124841-2012-00126
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING PROCEDURE, THERE WAS THERMAL INJURY TO THE SKIN OF THE LOWER LEG. TREATMENT FOR THIS WAS AN INCISION AND REMOVAL OF THE AFFECTED TISSUE INCLUDING SUBCUTANEOUS AND SKIN STRUCTURES. CHAD KELLER CLINICAL SPECIALIST STATED THE PT IS DOING FINE AND THIS WAS AN ELECTIVE PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSAPH PLUS, EVH VIRTUOSAPH PLUS GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA 27K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention