BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8886983371 DXT BI 1 90CM T-25

    MDR report key: 493132 · Received October 28, 2003

    Report

    Report Number
    9681850-2003-00004
    Event Type
    Injury
    Date Received
    October 28, 2003
    Date of Event
    August 25, 2002
    Report Date
    September 15, 2003
    Manufacturer
    GOSPORT - USS
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE PT EXPERIENCED DEHISCENCE OF AN ABDOMINAL WOUND CLOSURE DUE TO PT COUGHING. THE SUTURES BROKE AND THERE WAS BLEEDING. THE PT WAS BROUGHT INTO THE O.R. AND THE WOUND WAS RESUTURED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8886983371 DXT BI 1 90CM T-25 ABSORBABLE SYNTHETIC SUTURE GAM GOSPORT - USS NA E1G456K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other