BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK SUTURE PRODUCT

    MDR report key: 1578981 · Received January 13, 2010

    Report

    Report Number
    2210968-2010-00029
    Event Type
    Death
    Date Received
    January 13, 2010
    Report Date
    December 15, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN "ARTERIORECTOMY" AND STENT PLACEMENT DURING AN ENDARTERECTOMY IN 2008. THE PT BEGAN HEMORRHAGING FROM THE SITE AND WAS NOT TREATED, LEADING TO LOSS OF OXYGEN TO THE BRAIN, COMA AND CONTINUED TO DETERIORATE UNTIL HER DEATH FOUR DAYS LATER. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SUTURE PRODUCT SUTURE GAO ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| L| R