BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUMINATED DIRECT VIEW RETRACTOR

    MDR report key: 652743 · Received December 13, 2005

    Report

    Report Number
    2242056-2005-00002
    Event Type
    Injury
    Date Received
    December 13, 2005
    Date of Event
    October 20, 2005
    Report Date
    December 9, 2005
    Manufacturer
    ALTO DEVELOPMENT CORP
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A VEIN HARVESTING PROCEDURE," ONE OF THE ADJUSTABLE LIMBS OF THE DEVICE POKED THROUGH THE SKIN ON THE LEG OF THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMINATED DIRECT VIEW RETRACTOR SURGICAL RETRACTOR GAD ALTO DEVELOPMENT CORP NA 0003

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention