BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 494377 · Received November 7, 2003

    Report

    Report Number
    1219930-2003-00253
    Event Type
    Death
    Date Received
    November 7, 2003
    Report Date
    October 15, 2003
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A US SURGICAL PRODUCT WAS INVOLVED IN A RECENT PATIENT DEATH. THE ACCOUNT HAS BEEN CONTACTED SEVERAL TIMES FOR ADDITIONAL INFORMATION. AT THIS TIME, THE ACCOUNT WILL NOT RELEASE ANY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA INSTRUMENT DISPOSABLE STAPLER GAG NORTH HAVEN - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death