BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOPLEGIA DELIVERY SET

    MDR report key: 1023730 · Received March 25, 2008

    Report

    Report Number
    6000002-2008-06342
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THERE WAS A HAIR-LIKE UNKNOWN MATERIAL FOUND INSIDE THE POUCH BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPLEGIA DELIVERY SET CARDIOPLEGIA DELIVERY SET DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL CDS004 58420627

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other