BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-FLASH GERMICIDAL EXCHANGE DEVICE

    MDR report key: 196050 · Received November 5, 1998

    Report

    Report Number
    1423500-1998-01881
    Event Type
    Injury
    Date Received
    November 5, 1998
    Date of Event
    October 5, 1998
    Report Date
    October 5, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED PT DEVELOPED PERITONITIS AFTER USING THE UV FLASH DEVICE. HEALTH CARE PROFESSIONAL STATED PT CALLED WHEN SHE STARTED TO FEEL SICK AND REPORTED THAT THE UV FLASH DID NOT GO THROUGH FLASH CYCLE. PT STATED THIS HAPPENED SEVERAL TIMES AND PT COULD NOT REMEMBER IF DEVICE ALARMED OR NOT. HEALTH CARE PROFESSIONAL REPORTED THE UV FLASH WAS CHECKED AT THE CTR AND WAS FOUND TO BE WORKING PROPERLY, BUT REQUESTED DEVICE BE SWAPPED AND EVALUATED. TREATMENT CONSISTED OF ONE DOSE OF 2 GRAMS VANCOMYCIN AND 80 MG GENTAMYCIN. PERITONITIS HAS BEEN RESOLVED WITH MEDICATION. MICROORGANISM PRESENT STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH GERMICIDAL EXCHANGE DEVICE UV-FLASH KDJ BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other