BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREP KIT SISTEMA DE DESCONEXAODESCARTAVEL P/DPI/DPA

    MDR report key: 1173446 · Received September 23, 2008

    Report

    Report Number
    1423500-2008-00816
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BAXTER HOSPITALAR LTDA BRAZIL
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANION SAMPLE IS AVAILABLE FOR EVALUATION IN ADDITION TO TWO ACTUAL SAMPLES. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    ON 08/29/08 THE PT'S NURSE CONTACTED BAXTER'S TECHNICAL REP TO REPORT THAT A PT HAD DEVELOPED PERITONITIS. THE PT INFORMED THE NURSE THAT THE CORRECT PRODUCT HANDLING PROCEDURE WAS USED AT THE TIME OF THERAPY BUT SHE OBSERVED CRACKED MINICAPS BEFORE THE PERITONITIS SYMPTOMS. THE PT WAS ADMITTED TO THE HOSPITAL IN 2008, AND WAS DISCHARGED FIVE DAYS LATER. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREP KIT SISTEMA DE DESCONEXAODESCARTAVEL P/DPI/DPA 78KDJ KDJ BAXTER HOSPITALAR LTDA BRAZIL PS33S4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R