BEUDAMED
    FDA Adverse Event Summary report: N

    MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS)

    MDR report key: 1311849 · Received February 3, 2009

    Report

    Report Number
    1311849
    Date Received
    February 3, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 3, 2009
    Manufacturer
    WESCOR, INC.
    Product Code
    KTB
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    AN INFANT PATIENT UNDERWENT SWEAT A CHLORIDE TEST TO RIGHT ARM PER LAB TECHNICIAN. PT STARTED TO CRY DURING FIVE MINUTE TEST. RN REMOVED BAND AND ELECTRODES FROM RIGHT ARM. THE RIGHT HAND WAS BLUISH IN COLOR UNTIL IMMEDIATELTY AFTER BAND RELEASED. A HALF DOLLAR SIZE AREA OF REDNESS WAS NOTED ON RIGHT ANTERIOR FOREARM WITH FOUR SMALL PINPOINT AREAS OF BROWNISH BLUE SKIN. INDENTATION WAS NOTED TO RIGHT WRIST FROM BLACK BAND. PEDIATRICIAN NOTIFIED. THE AFFECTED AREA WAS IMMEDIATELY CLEANSED WITH STERILE WATER. NEOSPORIN APPLIED AND THEN DRESSED WITH KERLIX GAUZE DRESSING.====================== MANUFACTURER RESPONSE FOR SWEAT CHLORIDE TEST/ PILOGEL DISCS, WESCOR MACRODUCT SYSTEM======================I TALKED WITH MFR WHO WILL BE SENDING A LOANER UNIT. HE ALSO RECOMMENDED A PARENT EDUCATION SHEET WHICH IS INCLUDED IN A SUPPLY KIT. SEVERAL FOLLOW-UP AND USER QUESTIONS WERE DISCUSSED. I WILL FOLLOW-UP WITH THE COMPANY WHO SEEMS VERY INTERESTED IN PATIENT WELL BEING AND PATIENT SAFETY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS) DEVICE, IONTOPHORESIS KTB WESCOR, INC. * 100754

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO NO OTHER THERAPIES| NO OTHER THERAPIES