BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOUS-SPRAY APPLICATOR W/3CM MXING TIP

    MDR report key: 2913246 · Received January 8, 2013

    Report

    Report Number
    2183425-2013-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    May 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPRAY TIP CAME OFF OF THE APPLICATOR INTO THE SURGICAL WOUND. THE PT WAS INFORMED AND NO PAIN AT THAT TIME ((B)(6) 2012). FIVE MONTHS POST-OP, THE PT PRESENTED TO ER WITH PAIN; SURGEON DECIDED TO REMOVE TIP. THE TIBIAL IMPLANT ALSO HAD TO BE REPLACED DUE TO THE WEAR FROM THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10217 VISCOUS-SPRAY APPLICATOR W/3CM MXING TIP SYRINGE, IRRIGATING, NON-DENTAL KYZ MICROMEDICS, INC. ABS-10051 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention