BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOUS-SPRAY APPLICATOR W/3CM MXING TIP

    MDR report key: 2913324 · Received January 8, 2013

    Report

    Report Number
    2183425-2013-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 7, 2013
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    KYZ
    PMA / PMN Number
    K881020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SPRAY TIP DISLODGED FROM SPRAY APPLICATOR AND WAS DETECTED BY X-RAY. PT TAKEN BACK TO OPERATING ROOM FOR REMOVAL OF TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9933 VISCOUS-SPRAY APPLICATOR W/3CM MXING TIP SYRINGE, IRRIGATING, NON-DENTAL KYZ MICROMEDICS, INC. ABS-10051 126837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention