BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENDALL LAP SPONGE (VISTEC X-RAY)

    MDR report key: 406427 · Received July 19, 2002

    Report

    Report Number
    406427
    Event Type
    Injury
    Date Received
    July 19, 2002
    Date of Event
    March 21, 2002
    Report Date
    July 16, 2002
    Manufacturer
    KENDALL HEALTHCARE PRODUCTS
    Product Code
    GDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2002: LAPAROTOMY WITH SIGMOID COLON RESECTION AND PARTIAL CYSTECTOMY. 04/2002: E.R. FOR NAUSEA AND VOMITING. 05/02: E.R., THEN ADMITTED FOR SEVERE URINARY TRACT INFECTION AND PROBABLE FISTULA. 05/- 06/2002: GAUZE FOUND IN ABDOMEN. SIGMOID COLECTOMY AND CYSTOUROSCOPY AND PARTIAL CYSTECTOMY. 07/2002: SCHEDULED REVERSAL OF TEMPORARY COLOSTOMY NEEDED TO HEAL THE FISTULA CAUSED BY THE GAUGE SPONGE APPARENTLY LEFT IN ABDOMEN AT THE 03/2002 SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL LAP SPONGE (VISTEC X-RAY) SURGICAL LAP SPONGE GDY KENDALL HEALTHCARE PRODUCTS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R