BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN FLASH

    MDR report key: 1222101 · Received November 5, 2008

    Report

    Report Number
    1423500-2008-00889
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 3, 2008
    Report Date
    October 6, 2008
    Manufacturer
    MED-TECH LTD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OF IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FOREIGN FACILITY REPORTED THAT A MALE PATIENT WAS HOSPITALIZED IN 2008, FOR A DIAGNOSIS OF PERITONITIS AFTER USING DIANEAL AND EXTRANEAL SOLUTION AND A UV FLASH DEVICE. THE PATIENT WAS TREATED WITH SEFIROM. THE NEXT DAY, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS DETECTED FROM THE PATIENT'S EXIT CATHETER SITE. THE PERITONEAL CULTURE WAS NEGATIVE AT THIS TIME. IN THE SAME MONTH, THE WHITE BLOOD CELL (WBC) COUNT IN THE EFFLUENT WAS 1130/MM3. THE PATIENT RECEIVED SULPERAZON AS TREATMENT FOR AN UNKNOWN LENGTH OF THERAPY. THE FOLLOWING MONTH, THE PATIENT HAD NOT YET RECOVERED. TWO DAYS LATER, THE PERITONEAL EFFLUENT WAS CLEAR. THE NURSE INDICATED THAT SHE THOUGHT THAT THE EVENT WAS POSSIBLY RELATED TO THE UV FLASH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN FLASH 78KDJ KDJ MED-TECH LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R