BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3032774 · Received March 29, 2013

    Report

    Report Number
    2134070-2013-00071
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE OBTURATOR FRACTURED OFF INTO THE PATIENT'S SHOULDER AND WAS RECOVERED BY THE SURGEON. THERE WAS INCREASED OPERATING ROOM TIME DUE TO LOCATING THE BROKEN PIECE. THE PATIENT WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130443 NA GEA GEA STERILMED, INC. ARTAR-6540

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR