BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 80909 · Received April 1, 1997

    Report

    Report Number
    1527736-1997-00418
    Event Type
    Death
    Date Received
    April 1, 1997
    Report Date
    March 31, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ARTERY BYPASS GRAFT. IT WAS REPORTED THE VEIN HARVESTING INSTRUMENTS WERE USED DURING THE CASE. THE PT REPORTEDLY BLED OUT AND EXPIRED IN THE RECOVERY ROOM. NO DETAILS ARE AVAILABLE AT THIS TIME REGARDING SOURCE OF BLEEDING OR OTHER CIRCUMSTANCES. THIS OCCURRED WITHIN THE PAST 2 WEEKS, BUT NO SPECIFIC OPERATIVE DATE PROVIDED TO REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK GAJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death