BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTISWAB

    MDR report key: 946711 · Received October 17, 2007

    Report

    Report Number
    946711
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 17, 2007
    Manufacturer
    REMEL , INC.
    Product Code
    JSL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE PULLED THE PRODUCT FROM THE STORAGE AREA. SHE REMOVED THE EXTERIOR PACKAGING AND NOTICED THERE WAS MOLD GROWING ON THE SWAB. THE PRODUCT WAS NEVER USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTISWAB SWAB, BACTERIA SAMPLE JSL REMEL , INC. * 538508

    Patients

    Seq Age Sex Outcome Treatment
    1 *