BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSUTURE COMPANY

    MDR report key: 16974 · Received May 12, 1994

    Report

    Report Number
    16974
    Event Type
    Injury
    Date Received
    May 12, 1994
    Date of Event
    October 13, 1993
    Report Date
    October 14, 1993
    Manufacturer
    AUTOSUTURE COMPANY
    Product Code
    HDH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE, LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. PERFORATION OF MESENTERIC ARTERY AND HEMATOMA FORMATION OF RETRO-PERITONEAL AREA, FOLLOWING "INITAL" PLACEMENT OF DISPOSABLE VERRES NEEDLE AND TROCAR. MORE INVASIVE AND CORRECTIVE INTERVENTION REQUIRED. EXPLORATORY LAPAROTOMY, LIGATION OF BLEEDING MESENTERIC ARTERY AND EXPLORATION OF THE RETRO-PERITONEAL SPACE/AROTA AND URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE COMPANY SURGINEEDLE 120 MM HDH AUTOSUTURE COMPANY 120 MM SURGINEEDLE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R