BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE MIDSTREAM SPECIMEN KIT

    MDR report key: 80353 · Received April 1, 1997

    Report

    Report Number
    MW1011068
    Event Type
    Malfunction
    Date Received
    April 1, 1997
    Report Date
    March 10, 1997
    Manufacturer
    COLUMBIA DIAGNOSTICS
    Product Code
    JXA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A SPIDER WAS FOUND INSIDE A STERILE SEALED MIDSTREAM URINE COLLECTION SPECIMEN KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINE MIDSTREAM SPECIMEN KIT URINE MIDSTREAM SPECIMEN KIT JXA COLUMBIA DIAGNOSTICS B2523P UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *