BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITOSWAB

    MDR report key: 11684995 · Received April 16, 2021

    Report

    Report Number
    MW5100835
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 14, 2021
    Manufacturer
    CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD.
    Product Code
    QMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CITOSWAB TUBE BROKE. DISCOVERED IN LAB WHEN TECH WAS PREPARING TO DO TEST. NO VTM HAD SPILLED OUT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580072 CITOSWAB TRANSPORT MEDIUM, NOTIFIED PER THE VTM GUIDANCE QMC CITOTEST SCIENTIFIC / CITOTEST LABWARE MANUFACTURING CO., LTD. 092044

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR