BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201060 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00028
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    January 10, 2010
    Report Date
    September 24, 2014
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT THE PATIENT EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666730 DESARA SURGICAL MESH OTN CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other