BEUDAMED
    FDA Adverse Event Summary report: N

    CONTOURA 100 / 1080

    MDR report key: 3251925 · Received July 22, 2013

    Report

    Report Number
    1419652-2013-00198
    Date Received
    July 22, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z.O.O.
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN INDICATED THAT THE WELD ON THE FOLDING SAFETY SIDE FAILED. NO DEATH OR SERIOUS INJURY HAS BEEN REPORTED. NO INJURIES WERE SUSTAINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340818 CONTOURA 100 / 1080 OSI ARJOHUNTLEIGH POLSKA SP Z.O.O. C1080

    Patients

    Seq Age Sex Outcome Treatment
    1 Other