BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAC 1820 M

    MDR report key: 932952 · Received October 24, 2007

    Report

    Report Number
    1056553-2007-00004
    Event Type
    Other
    Date Received
    October 24, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 23, 2007
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    KNW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR REVIEW OF THE DHR FOR LOT # 070735 INDICATED THAT THE STERILIZATION RECORDS AND THE ENDOTOXIN TESTING WAS COMPLETED WITHOUT ANY ISSUES. REMINGTON MEDICAL, INC. IS SENDING PRODUCT FROM THE SAME LOT # TO AN OUTSIDE LAB FOR STERILITY TESTING. THE RESULTS OF THIS TESTING WILL BE COMPLETED MID-NOVEMBER 2007.

    Description of Event or Problem · 1

    UROLOGY OFFICE USED TWO OF OUR 1820M PROSTATE BIOPSY NEEDLES ON TWO DIFFERENT PATIENTS. THE BIOPSIES WERE PERFORMED BY TWO DIFFERENT DOCTORS IN THE UROLOGY OFFICE A WEEK OR TWO APART. BOTH PATIENTS DEVELOPED AN INFECTION THAT REQUIRED HOSPITALISATION TO RESOLVE. REMINGTON MEDICAL, INC. FOUND OUT ABOUT THE EVENT WHEN OUR SALES REPRESENTATIVE CALLED ON THE OFFICE AS A FOLLOW-UP. OUR QA REPRESENTATIVE SPOKE WITH THE DOCTOR. DR. COULD NOT AND WOULD NOT CONFIRM THAT HE FELT OUR NEEDLES CAUSED THE INFECTION. BOTH PATIENTS ARE INFECTION FREE AND DOING FINE PER DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAC 1820 M PROSTATE BIOPSY NEEDLE KNW REMINGTON MEDICAL, INC. NAC 1820 M 070735

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization