BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY IODOFORM STRIPS 1X5 STRL

    MDR report key: 3375796 · Received August 23, 2013

    Report

    Report Number
    1018120-2013-00004
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Report Date
    July 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH PACKING STRIP. THE CUSTOMER STATES THAT A PT CAVITY WAS REPACKED BY THE SURGERY RESIDENT WITH 1 INCH PACKING STRIPS. THE STRIPS BECAME LODGED IN THE CAVITY WHEN THE PACKING STRIPS WERE TO BE CHANGED. THE PT WAS TAKEN TO SURGERY AND A 4 INCH INCISION WAS CREATED AND THE STRIPS WERE REMOVED USING HEMOSTATS. THIS WAS WHEN THE SURGEON DISCOVERED THAT THE 1 INCH PACKING STRIPS HAD BROKEN INTO 4 SEPARATE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411245 CURITY IODOFORM STRIPS 1X5 STRL PACKING STRIPS GEL COVIDIEN 7833 130000417462X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK