BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOMEY IRRIGATION SYRINGE

    MDR report key: 4173479 · Received October 10, 2014

    Report

    Report Number
    1018233-2014-00272
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 17, 2014
    Manufacturer
    PRODUCTOS PARA CUIDADO DE LA SALUD
    Product Code
    KYZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS, ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP DETACHES FROM THE SYRINGE TIP EASILY - DOES NOT FIT SECURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642985 TOOMEY IRRIGATION SYRINGE KYZ PRODUCTOS PARA CUIDADO DE LA SALUD NA NGWL2234

    Patients

    Seq Age Sex Outcome Treatment
    1