BEUDAMED
    FDA Adverse Event Summary report: N

    FIRST STEP BEDSIDE PRECLEAN KIT

    MDR report key: 4563426 · Received February 24, 2015

    Report

    Report Number
    MW5041020
    Date Received
    February 24, 2015
    Date of Event
    February 24, 2015
    Report Date
    February 24, 2015
    Manufacturer
    CYGNUS MEDICAL
    Product Code
    JCB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A FEW WEEKS AGO IT WAS REPORTED BY MY FACILITY'S INFECTIOUS DISEASE PHYSICIAN THAT THERE WAS A NOTABLE UPTAKE IN STENOTROPHOMONAS MALTOPHILIA SEEN IN BRONCHOSCOPY CASES, PARTICULARLY WASHES AND LAVAGES, BASED ON A SERIES OF LAB RESULTS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131308 FIRST STEP BEDSIDE PRECLEAN KIT PRECLEAN KIT JCB CYGNUS MEDICAL TK200 EX20150514A
    131309 FIRST STEP BEDSIDE PRECLEAN KIT PRECLEAN KIT JCB CYGNUS MEDICAL TK200 EX20160712A

    Patients

    Seq Age Sex Outcome Treatment
    1