BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON RELOADABLE LINEAR STAPLE

    MDR report key: 2002798 · Received February 18, 2011

    Report

    Report Number
    MW5019492
    Event Type
    Death
    Date Received
    February 18, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ETHICON LLC JOHNSON AND JOHNSON CO.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON (B)(6) 2010, WITH C/O PERSISTENT NAUSEA AND VOMITING FOR FOUR DAYS. BOWEL OBSTRUCTION PER SMALL BOWEL SERIES. PT TAKEN TO SURGERY ON (B)(6) 2010 FOR SMALL BOWEL OBSTRUCTION WITH ETHICON RELOADABLE LINEAR STAPLER 60 MM USED. PT HAD C/O ABDOMINAL PAIN AND EMESIS. NG INSERTED WITH NO RELIEF. FREE AIR NOTED ON ABDOMINAL XRAY. PT RETURNED TO SURGERY ON (B)(6) 2011 FOR RESECTION OF STAPLE LINE. PT EXPIRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON RELOADABLE LINEAR STAPLE ETHICON STAPLER GDW ETHICON LLC JOHNSON AND JOHNSON CO. TX60B

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death