BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYNECARE INTERGEL

    MDR report key: 459304 · Received April 17, 2003

    Report

    Report Number
    MW1028390
    Event Type
    Death
    Date Received
    April 17, 2003
    Date of Event
    February 9, 2003
    Report Date
    March 27, 2003
    Manufacturer
    *
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT TAH/LSO/LOA DURING WHICH INTERGEL WAS PLACED TO PREVENT POST-OP ADHESIONS. THE PT HAD AN UNRECOGNIZED RECTAL PERFORATION AND EXPIRED ON POST OP DAY 5 FROM SEPSIS AND ARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE INTERGEL * MCN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death