BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 17904 · Received September 6, 1994

    Report

    Report Number
    17904
    Event Type
    Death
    Date Received
    September 6, 1994
    Date of Event
    May 11, 1993
    Report Date
    September 2, 1994
    Manufacturer
    ULTI-MED INTERNATIONAL, INC.
    Product Code
    GDY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/11/93, A MORBIDLY OBESE 31-YR-OLD PT UNDERWENT EMERGENCY CESAREAN SECTION AND DELIVERED HEALTHY FEMALE. ON 3/1/94 PT WAS READMITTED WITH DIAGNOSIS OF CHRONIC CHOLECYSTITIS. ON 3/2/94 PT UNDERWENT EXPLORATORY LAPAROTOMY SEGMENTAL RESECTION OF JEJUNUM AND ILIUM WITH ANASTOMOSIS, SEGMENTAL RESECTION OF SMALL COLON WITH END COLOSTOMY. DRAINAGE AND DEBRIDEMENT OF INTRAABDOMINAL ABSCESS. POST DIAGNOSIS WAS EROSION OF JEJUNUM BY FOREIGN BODY. ON 3/8/94 PT EXPIRED. CAUSE OF DEATH: ADULT RESPIRATORY DISTRESS SYNDROME CAUSED BY INTRABDOMINAL COLLECTION AND SEPSIS SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN Implant SPONGE, LAPAROSCOPIC GDY ULTI-MED INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death