BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STICK SPONGE PVP PAINT

    MDR report key: 2463635 · Received February 2, 2012

    Report

    Report Number
    9612030-2012-00008
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Report Date
    January 6, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A PVP STICK SPONGE. THE CUSTOMER REPORTS THE SPONGE SLIPPED OFF THE STICK AND STAYED INSIDE PATIENT'S VAGINA. SPONGE WAS REMOVED BY THE PHYSICIAN, THE MEANS OF REMOVAL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STICK SPONGE PVP PAINT STICK SPONGE KXF COVIDIEN 41550 1G064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN